510(k) · Cleared

Cleared

Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue Patient Monitors MP5, MP2, X2 Model

K101600510(k) AbbreviatedCleared Aug 31, 201084-day reviewClass II21 CFR 870.2700

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · DQA Oximeter

Cleared on Aug 31, 2010 as substantially equivalent to K043517 (Nihon Kohden America, Inc., 2005) and 34 other predicates after an 84-day review. Its family tree reaches back 29 generations to 1994. 2 of the 267 devices in its family, counting itself, have a Class I recall. 37 later devices descend from it.

Decided: Aug 31, 2010
Review: 84 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 35

Its longest line of descent runs back 29 generations to K941811 (1994). 229 ancestors in all, the oldest K844187 (1985). 37 later devices descend from it, 2 citing it directly. 2 of the 267 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 29 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
25 generations between
3 generations backK083517 Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · Recalled
2 generations backK091927 Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
1 generation backK100939 Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
This deviceK101600 Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
Descendant · cites it directly · 36 of its ownK111905 Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011
Descendant · 2 generations on · 35 of its ownK122223 New: Intellivue CL Respiration Pod New: Specialized Assessory…Philips Medizin Systeme Boeblingen GmbH · 2013
Descendant · 3 generations on · 24 of its ownK151736 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015
Descendant · 4 generations on · 23 of its ownK161767 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH · 2017
Descendant · 3 generations on · 20 of its ownK132320 Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2014

Show all 29 generations

Root · 29 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
28 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
27 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
26 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
25 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
24 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
23 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
22 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
21 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
20 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
19 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
18 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
17 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
16 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
15 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
14 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
13 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
12 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
11 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
10 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
9 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
8 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
7 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
6 generations backK061610 Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
5 generations backK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006
4 generations backK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
3 generations backK083517 Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · Recalled
2 generations backK091927 Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
1 generation backK100939 Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
This deviceK101600 Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010

Showing 5 of 37 descendants. See all descendants

Descendants cleared per year

2011high 6 (2024) · low 0 (2012)2026

Class I recalls in this family

K031187 Heartstart MRX, Model M3535Adirect predicate · 2003
K970209 Capnocheck Plus6 generations back · 1997

Most influential descendants

Showing 5 of 37 · See all

K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · cites it directly36descendants
K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH · 2013 · 2 generations on35descendants
K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015 · 3 generations on24descendants
K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH · 2017 · 4 generations on23descendants
K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2014 · 3 generations on20descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−29	K941811	HP M1175A, M1176A, Component Monitoring System	Hewlett-Packard Co.	1994	—
−28	K960934	HP M1205A Omnicare Component Monitor System Model 24	Hewlett-Packard Co.	1996	—
−27	K981376	Hewlett-Packard M1205A Viridia 24 CT	Hewlett-Packard Co.	1999	—
−26	K990125	HP Viridia Component Monitoring System, Model Rev. K	Hewlett-Packard GmbH	1999	—
−25	K990972	HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…	Hewlett-Packard GmbH	1999	—
−24	K013199	Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…	Philips Medical Systems, Inc.	2001	—
−23	K020531	Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…	Philips Medical Systems	2002	—
−22	K021778	Philips Component Compact Monitor, Release a.04, Model #M1275B	Philips Medical Systems	2002	—
−21	K023871	M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…	Philips Medical Systems	2002	—
−20	K030038	Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…	Philips Medical Systems, Inc.	2003	—
−19	K031481	The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20	Philips Medizin Systeme Boblingen GmbH	2003	—
−18	K032858	The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…	Philips Medizin Systeme Boblingen GmbH	2003	—
−17	K040304	Philips Intellivue Patient Monitor, Models MP40 & MP50	Philips Medizin Systeme Boeblingen GmbH	2004	—
−16	K041235	Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors	Philips Medizin Systeme Boeblingen GmbH	2004	—
−15	K042845	The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…	Philips Medizin Systeme Boblingen GmbH	2004	—
−14	K050141	The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…	Philips Medizin Systeme Boeblingen GmbH	2005	—
−13	K050762	Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…	Philips Medizin Systeme Boeblingen GmbH	2005	—
−12	K051106	The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…	Philips Medizin Systeme Boeblingen GmbH	2005	—
−11	K052801	Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50…	Philips Medizin Systeme Boeblingen GmbH	2005	—
−10	K053522	Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors…	Philips Medizin Systeme Boeblingen GmbH	2006	—
−9	K060221	The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue…	Philips Medizin Systeme Boeblingen GmbH	2006	—
−8	K060541	The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient…	Philips Medizin Systeme Boblingen GmbH	2006	2
−7	K061052	The Philips Intellivue Patient Monitors, Models…	Philips Medical Systems North America, Inc.	2006	—
−6	K061610	Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…	Philips Medizin Systeme Boeblingen GmbH	2006	—
−5	K063315	Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80…	Philips Medizin Systeme Boeblingen GmbH	2006	—
−4	K071426	MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2007	—
−3	K083517	Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2009	2
−2	K091927	Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2009	—
−1	K100939	Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2010	—
0 (this device)	K101600	Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2010	—
+1	K111905	Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2011	—
+2	K122223	New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp…	Philips Medizin Systeme Boeblingen GmbH	2013	—
+3	K151736	Philips IntelliVue GuardianSoftware	Philips Medizin Systeme Boblingen GmbH	2015	—
+4	K161767	Philips IntelliVue GuardianSoftware	Philips Medizin Systeme Boeblingen GmbH	2017	—
+3	K132320	Intellivue CL Respiration Pod	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1985	2	0
1986	1	0
1987	1	0
1989	4	0
1990	8	0
1991	9	0
1992	7	0
1993	6	0
1994	2	0
1995	9	0
1996	10	0
1997	9	1
1998	17	0
1999	12	0
2000	20	0
2001	7	0
2002	15	0
2003	14	1
2004	18	0
2005	9	0
2006	8	0
2007	5	0
2008	4	0
2009	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2013	2	0
2014	1	0
2015	1	0
2017	1	0
2018	2	0
2019	2	0
2020	3	0
2021	2	0
2022	4	0
2023	4	0
2024	6	0
2025	6	0
2026	2	0

FIG. 1 — Lineage of K101600, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DQA device

#1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (35)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K043517	Transmitter, ZS-940PA Series Summary page 2 …lliVue CL SpO2 Pod and IntelliVue CL NBP Pod are substantially equivalent to the previously cleared Nihon Kohden Transmitter ZS-940PA series marketed pursuant to K<043517, Philips IntelliVue Telemetry System Transceiver TRx4841A marketed pursuant to K<081793, K041741, 1<0403S7, and Philips Mul…	Nihon Kohden America, Inc.	2005	—
*	K081793	Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry… Summary page 2 …cleared Nihon Kohden Transmitter ZS-940PA series marketed pursuant to K<043517, Philips IntelliVue Telemetry System Transceiver TRx4841A marketed pursuant to K<081793, K041741, 1<0403S7, and Philips Multi- Measurement Server M3000A/M3001A marketed pursuant to K<001333, 1<013427, K<020531,…	Philips Medizin Systeme Boeblingen GmbH	2008	—
*	K041741	M3290A Intellivue Information Center Software Release F.0 and M4840A Philips Telemetry… Summary page 2 …Nihon Kohden Transmitter ZS-940PA series marketed pursuant to K<043517, Philips IntelliVue Telemetry System Transceiver TRx4841A marketed pursuant to K<081793, K041741, 1<0403S7, and Philips Multi- Measurement Server M3000A/M3001A marketed pursuant to K<001333, 1<013427, K<020531, 1<030973,…	Philips Medical Systems, Inc.	2004	4
*	K040357	M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry… Summary page 2 …Transceiver TRx4841A is substantially equivalent to previously cleared IntelliVue Telemetry System Transceiver TRx484lA marketed pursuant to K<081793, 1<041741, 1<040357. 4. Description of the devices The new Philips IntelliVue CL SpO 2 Pod is a small, battery powered, wrist worn pulse oxime…	Philips Medical Systems, Inc.	2004	—
*	K001333	Agilent Component Monitoring System, Agilent Multi-Measurement Server and Compact… Summary page 2 …Telemetry System Transceiver TRx4841A marketed pursuant to K<081793, K041741, 1<0403S7, and Philips Multi- Measurement Server M3000A/M3001A marketed pursuant to K<001333, 1<013427, K<020531, 1<030973, K033715, 1<062268, K090360. The new reusable NPP cuffs 989803163171, 989803163191, 98980…	Agilent Technologies Deutschland GmbH	2000	—
*	K013427	Modification to:Philips M3000A/M3046A Compact Portable Patient Monitor, Models Philips… Summary page 2 …stem Transceiver TRx4841A marketed pursuant to K<081793, K041741, 1<0403S7, and Philips Multi- Measurement Server M3000A/M3001A marketed pursuant to K<001333, 1<013427, K<020531, 1<030973, K033715, 1<062268, K090360. The new reusable NPP cuffs 989803163171, 989803163191, 989803163211 and E…	Philips Medical Systems, Inc.	2001	—
*	K020531	Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release… Summary page 2 …ceiver TRx4841A marketed pursuant to K<081793, K041741, 1<0403S7, and Philips Multi- Measurement Server M3000A/M3001A marketed pursuant to K<001333, 1<013427, K<020531, 1<030973, K033715, 1<062268, K090360. The new reusable NPP cuffs 989803163171, 989803163191, 989803163211 and Extension A…	Philips Medical Systems	2002	—
*	K030973	Picosat II SPO2 Pulse Oximetry Module Summary page 2 …4841A marketed pursuant to K<081793, K041741, 1<0403S7, and Philips Multi- Measurement Server M3000A/M3001A marketed pursuant to K<001333, 1<013427, K<020531, 1<030973, K033715, 1<062268, K090360. The new reusable NPP cuffs 989803163171, 989803163191, 989803163211 and Extension Air Hose 98…	Philips Medical Systems	2003	—
*	K033715	Picosat II SP02 Pulse Oximetry Module and M3001A Multi-Measurement Server Summary page 2 …rketed pursuant to K<081793, K041741, 1<0403S7, and Philips Multi- Measurement Server M3000A/M3001A marketed pursuant to K<001333, 1<013427, K<020531, 1<030973, K033715, 1<062268, K090360. The new reusable NPP cuffs 989803163171, 989803163191, 989803163211 and Extension Air Hose 98980316313…	Philips Medical Systems, Inc.	2004	3
*	K062268	Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option A03 Summary page 2 …ursuant to K<081793, K041741, 1<0403S7, and Philips Multi- Measurement Server M3000A/M3001A marketed pursuant to K<001333, 1<013427, K<020531, 1<030973, K033715, 1<062268, K090360. The new reusable NPP cuffs 989803163171, 989803163191, 989803163211 and Extension Air Hose 989803163131 for the…	Philips Medical Systems North America Co.	2006	—
*	K090360	Philips M3001A Multi Measurement Server Summary page 2 …to K<081793, K041741, 1<0403S7, and Philips Multi- Measurement Server M3000A/M3001A marketed pursuant to K<001333, 1<013427, K<020531, 1<030973, K033715, 1<062268, K090360. The new reusable NPP cuffs 989803163171, 989803163191, 989803163211 and Extension Air Hose 989803163131 for the CL NBP…	Philips Medizin Systeme Boblingen GmbH	2009	—
*	K031187	Heartstart MRX, Model M3535A Summary page 2 …bstantially equivalent to the Philips reusable cuffs M1573A, M1574A, MTS75A marketed pursuant to K<001333, Philips Extension Air Hose Ml598B marketed pursuant to 1<031187. The new disposable NB3P cuffs 989803163181, 989803163201, 989803163221 for the CL NBP Pod are substantially equivalent to…	Philips Medical Systems	2003	Class I
*	K071885	Antimicrobial and Single-Patient Cuffs Summary page 2 …803163181, 989803163201, 989803163221 for the CL NBP Pod are substantially equivalent to the Philips disposable cuffs M4574B, M457SB, M4577B marketed pursuant to 1<071885, Hewlett-Packard/Philips disposable cuffs M1876A, M1877A, M1878A marketed pursuant to 1<941811, 1<925910, 1<923682, K<923343,…	Philips Medical Systems	2007	—
*	K941811	HP M1175A, M1176A, Component Monitoring System Summary page 2 …Philips disposable cuffs M4574B, M457SB, M4577B marketed pursuant to 1<071885, Hewlett-Packard/Philips disposable cuffs M1876A, M1877A, M1878A marketed pursuant to 1<941811, 1<925910, 1<923682, K<923343, 1<922058, 1<910490, 1<903771, 1<903523, K<900032, 1<896030, 1<882609. The modified reusable…	Hewlett-Packard Co.	1994	—
*	K925910	Hewlett-Packard Model M1018A TCPO2/TOPCO2 Module Summary page 2 …sposable cuffs M4574B, M457SB, M4577B marketed pursuant to 1<071885, Hewlett-Packard/Philips disposable cuffs M1876A, M1877A, M1878A marketed pursuant to 1<941811, 1<925910, 1<923682, K<923343, 1<922058, 1<910490, 1<903771, 1<903523, K<900032, 1<896030, 1<882609. The modified reusable 5p02 senso…	Hewlett-Packard Co.	1993	—
*	K923682	Model M1032A Vuelink Interface Plug-in Module Summary page 2 …fs M4574B, M457SB, M4577B marketed pursuant to 1<071885, Hewlett-Packard/Philips disposable cuffs M1876A, M1877A, M1878A marketed pursuant to 1<941811, 1<925910, 1<923682, K<923343, 1<922058, 1<910490, 1<903771, 1<903523, K<900032, 1<896030, 1<882609. The modified reusable 5p02 sensor Mobile CL…	Hewlett-Packard Co.	1992	—
*	K923343	Hewlett-Packard Model M1020A Pulse Oximeter Summary page 2 …M457SB, M4577B marketed pursuant to 1<071885, Hewlett-Packard/Philips disposable cuffs M1876A, M1877A, M1878A marketed pursuant to 1<941811, 1<925910, 1<923682, K<923343, 1<922058, 1<910490, 1<903771, 1<903523, K<900032, 1<896030, 1<882609. The modified reusable 5p02 sensor Mobile CL RSpO2-lA R…	Hewlett-Packard Co.	1993	—
*	K922058	Models M1175A and M1176A Component Monitoring Syst Summary page 2 …4577B marketed pursuant to 1<071885, Hewlett-Packard/Philips disposable cuffs M1876A, M1877A, M1878A marketed pursuant to 1<941811, 1<925910, 1<923682, K<923343, 1<922058, 1<910490, 1<903771, 1<903523, K<900032, 1<896030, 1<882609. The modified reusable 5p02 sensor Mobile CL RSpO2-lA Reusable…	Hewlett-Packard Co.	1992	—
*	K910490	Modified Monitoring System Models M1175A & M1176A Summary page 2 …eted pursuant to 1<071885, Hewlett-Packard/Philips disposable cuffs M1876A, M1877A, M1878A marketed pursuant to 1<941811, 1<925910, 1<923682, K<923343, 1<922058, 1<910490, 1<903771, 1<903523, K<900032, 1<896030, 1<882609. The modified reusable 5p02 sensor Mobile CL RSpO2-lA Reusable SpO2 Senso…	Hewlett-Packard Co.	1991	—
*	K903771	HP Model M1008B, Noninvasive Blood Pressure Module Summary page 2 …suant to 1<071885, Hewlett-Packard/Philips disposable cuffs M1876A, M1877A, M1878A marketed pursuant to 1<941811, 1<925910, 1<923682, K<923343, 1<922058, 1<910490, 1<903771, 1<903523, K<900032, 1<896030, 1<882609. The modified reusable 5p02 sensor Mobile CL RSpO2-lA Reusable SpO2 Sensor for Inte…	Hewlett-Packard Co.	1991	—
*	K903523	HP Model M1020A, Arterial Oxygen Sat/Pleth Module Summary page 2 …<071885, Hewlett-Packard/Philips disposable cuffs M1876A, M1877A, M1878A marketed pursuant to 1<941811, 1<925910, 1<923682, K<923343, 1<922058, 1<910490, 1<903771, 1<903523, K<900032, 1<896030, 1<882609. The modified reusable 5p02 sensor Mobile CL RSpO2-lA Reusable SpO2 Sensor for IntelliVue CL…	Hewlett-Packard Co.	1990	—
*	K900032	Model M1175A/M1176A with ST Segment Monitoring Summary page 2 …ewlett-Packard/Philips disposable cuffs M1876A, M1877A, M1878A marketed pursuant to 1<941811, 1<925910, 1<923682, K<923343, 1<922058, 1<910490, 1<903771, 1<903523, K<900032, 1<896030, 1<882609. The modified reusable 5p02 sensor Mobile CL RSpO2-lA Reusable SpO2 Sensor for IntelliVue CL SpO2 Pod i…	Hewlett-Packard Co.	1990	—
*	K896030	Hewlett-Packard Model M1016A CO2 & M1017A FI02 Summary page 2 …rd/Philips disposable cuffs M1876A, M1877A, M1878A marketed pursuant to 1<941811, 1<925910, 1<923682, K<923343, 1<922058, 1<910490, 1<903771, 1<903523, K<900032, 1<896030, 1<882609. The modified reusable 5p02 sensor Mobile CL RSpO2-lA Reusable SpO2 Sensor for IntelliVue CL SpO2 Pod is substantia…	Hewlett-Packard Co.	1989	—
*	K882609	Models M1175A & M1176A Component Monitoring System Summary page 2 …disposable cuffs M1876A, M1877A, M1878A marketed pursuant to 1<941811, 1<925910, 1<923682, K<923343, 1<922058, 1<910490, 1<903771, 1<903523, K<900032, 1<896030, 1<882609. The modified reusable 5p02 sensor Mobile CL RSpO2-lA Reusable SpO2 Sensor for IntelliVue CL SpO2 Pod is substantially equi…	Waltham Div. Hewlett Packard	1989	—
*	K081937	Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry… Summary page 2 …od is substantially equivalent to the Philips reusable SpO2 sensor M1192AN marketed pursuant to K<033715 and Nellcor disposable SpO2 sensor MAX-A marketed pursuant K081937. The modified disposable SpO2 sensor Mobile CL DSpO2-lA Single Patient SpO2 Sensor for IntelliVue CL SpO2 Pod is substantial…	Philips Medizin Systeme Boeblingen GmbH	2008	—
*	K091572	Disposable SPO2 Sensor M1134A Summary page 2 …e CL DSpO2-lA Single Patient SpO2 Sensor for IntelliVue CL SpO2 Pod is substantially equivalent to the Philips disposable SpO2 sensor M1134A marketed pursuant to K<091572 Philips reusable SpO2 sensor M1192AN marketed pursuant to K<033715, and Neilcor disposable SpO2 sensor MAX-A marketed pursuan…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2009	—
*	K062392	Philips MP5 Intellivue Patient Monitor Summary page 2 …MP2, 42 are substantially equivalent to previously cleared IntelliVue Patient Monitors MP5, MP5T, MP2, X2 marketed pursuant to 1<062392, 1<063725, 1<071426, 1<072070, 1<081793, 1K082633, 1<083228, K<083517, 1<091395, 1<100939. The modified Philips…	Philips Medizin Systeme Boeblingen GmbH	2006	—
*	K063725	MP5 Intellivue Patient Monitor Summary page 2 …re substantially equivalent to previously cleared IntelliVue Patient Monitors MP5, MP5T, MP2, X2 marketed pursuant to 1<062392, 1<063725, 1<071426, 1<072070, 1<081793, 1K082633, 1<083228, K<083517, 1<091395, 1<100939. The modified Philips IntelliVue…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2007	—
*	K071426	MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient… Summary page 2 …tially equivalent to previously cleared IntelliVue Patient Monitors MP5, MP5T, MP2, X2 marketed pursuant to 1<062392, 1<063725, 1<071426, 1<072070, 1<081793, 1K082633, 1<083228, K<083517, 1<091395, 1<100939. The modified Philips IntelliVue Telemetry…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2007	—
*	K072070	Philips MP2 and X2 Intellivue Patient Monitors Summary page 2 …ivalent to previously cleared IntelliVue Patient Monitors MP5, MP5T, MP2, X2 marketed pursuant to 1<062392, 1<063725, 1<071426, 1<072070, 1<081793, 1K082633, 1<083228, K<083517, 1<091395, 1<100939. The modified Philips IntelliVue Telemetry System Tra…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2007	—
*	K082633	Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50… Summary page 2 …ly cleared IntelliVue Patient Monitors MP5, MP5T, MP2, X2 marketed pursuant to 1<062392, 1<063725, 1<071426, 1<072070, 1<081793, 1K082633, 1<083228, K<083517, 1<091395, 1<100939. The modified Philips IntelliVue Telemetry System Transceiver TRx4841A…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2008	3
*	K083228	Philips Intellivue MP5 Patient Monitor Summary page 2 …IntelliVue Patient Monitors MP5, MP5T, MP2, X2 marketed pursuant to 1<062392, 1<063725, 1<071426, 1<072070, 1<081793, 1K082633, 1<083228, K<083517, 1<091395, 1<100939. The modified Philips IntelliVue Telemetry System Transceiver TRx4841A is substan…	Philips Medizin Systeme Boblingen GmbH	2008	—
*	K083517	Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80… Summary page 2 …lliVue Patient Monitors MP5, MP5T, MP2, X2 marketed pursuant to 1<062392, 1<063725, 1<071426, 1<072070, 1<081793, 1K082633, 1<083228, K<083517, 1<091395, 1<100939. The modified Philips IntelliVue Telemetry System Transceiver TRx4841A is substantially equivalent to p…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2009	2
*	K091395	MP5 Intellivue Patient Monitor Summary page 2 …ient Monitors MP5, MP5T, MP2, X2 marketed pursuant to 1<062392, 1<063725, 1<071426, 1<072070, 1<081793, 1K082633, 1<083228, K<083517, 1<091395, 1<100939. The modified Philips IntelliVue Telemetry System Transceiver TRx4841A is substantially equivalent to previously cl…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2009	—
*	K100939	Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70… Summary page 2 …ors MP5, MP5T, MP2, X2 marketed pursuant to 1<062392, 1<063725, 1<071426, 1<072070, 1<081793, 1K082633, 1<083228, K<083517, 1<091395, 1<100939. The modified Philips IntelliVue Telemetry System Transceiver TRx4841A is substantially equivalent to previously cleared In…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2010	—

Also cleared against K043517: 2 other devices →

What descends from it? (37)

See all 37

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K111905	Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2011	36
K131913	Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…	Philips Medizin Systeme Boeblingen GmbH	2013	0

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K031187Heartstart MRX, Model M3535APhilips Medical Systems · 2003 · Direct predicate · ◆ in the 2003 ancestors bar of FIG. 12 Class I recalls
K970209Capnocheck PlusBci Intl., Inc. · 1997 · 6 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 16 years and passes through 8 companies; a new generation was cleared every 4 months on median.
30 of the 229 ancestors have a recall of any class; 2 have a Class I recall.
Of its descendants, K111905 (Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, 2011) has gone furthest, with 36 descendants of its own.
2 other devices also cite its predicate K043517.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · DQA

15in 2025

2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007high 317 (2023) · low 97 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQA

3in 2024

2007high 32 (2018) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DQA

399in 2025

2007high 2,082 (2015) · low 164 (2011)2025

MAUDE reports naming product code DQA, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	20	122	6	325
2008	22	97	5	312
2009	35	117	29	281
2010	29	127	4	185
2011	15	195	1	164
2012	14	120	0	322
2013	15	182	0	468
2014	11	175	2	1,124
2015	13	158	1	2,082
2016	14	246	0	1,775
2017	9	200	0	1,190
2018	18	260	32	694
2019	19	158	0	548
2020	15	126	0	426
2021	10	174	0	553
2022	20	265	0	478
2023	13	317	0	392
2024	14	285	3	545
2025	15	182	0	399
2026	8	187	0	—

What is it indicated for?

The IntelliVue CL SpO 2 Pod is indicated for use by health care professionals whenever there is a need for monitoring the physiological patient parameters SpO2 and pulse rate wirelessly. The intended use of the IntelliVue CL SpO2 Pod when used together with IntelliVue Patient Monitors MP5, MP5T, MP2, X2, or with the IntelliVue Telemetry System Transceiver TRx4841A, is for monitoring, recording, and alarming arterial oxygen saturation and pulse rate of…

Read the full statement (395 words)

The IntelliVue CL SpO 2 Pod is indicated for use by health care professionals whenever there is a need for monitoring the physiological patient parameters SpO2 and pulse rate wirelessly.

The intended use of the IntelliVue CL SpO2 Pod when used together with IntelliVue Patient Monitors MP5, MP5T, MP2, X2, or with the IntelliVue Telemetry System Transceiver TRx4841A, is for monitoring, recording, and alarming arterial oxygen saturation and pulse rate of adult and pediatric patients inside hospitals. The device is intended for use by health care professionals. it is not intended for home use. The device is not a therapeutic device.

The IntelliVue CL NBP Pod is indicated for use by health care professionals whenever there is a need for monitoring the physiological patient parameters non-invasive blood pressure and pulse rate wirelessly.

The intended use of the IntelliVue CL NBP Pod when used together with IntelliVue Patient Monitors MP5, MP5T, MP2, X2, or with the IntelliVue Telemetry System Transceiver TRX4841A is for monitoring, recording, and alarming of systolic, diastolic, and mean pressure and pulse rate of adult and pediatric patients inside hospitals. The device is intended for use by health care professionals. It is not intended for home use. The device is not a therapeutic device.

The IntelliVue Patient Monitors MP5, MP5T, MP2, X2 are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside of the hospital environment. The MP2, X2, and MP5 monitors are also intended for use during patient transport outside of the hospital environment.

They are not intended for home use. The monitors are only for use on one patient at a time. They are not therapeutic devices.

The IntelliVue Telemetry System Transceiver TRx4841A is indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

Intended to provide ambulatory and bedside monitoring, recording and alarming of ECG and SpO2 parameters of adult and pediatric patients in transport and hospital environments.

It is intended to be used by trained healthcare personnel. It is not intended for home use. The device is only for use on one patient at a time. It is not for use with infant or neonatal patients.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101600 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101600: Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue Patient Monitors MP5, MP2, X2 Model.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101600

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026