510(k) · Cleared

Recalled · Class II · 2014

Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T, MP5SC

K131913510(k) AbbreviatedCleared Nov 26, 2013153-day reviewClass II21 CFR 870.2910Recalls 1

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

Philips Medizin Systeme Boeblingen GmbH · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

Cleared on Nov 26, 2013 as substantially equivalent to K101600 (Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, 2010) and 18 other predicates after a 153-day review. Its family tree reaches back 33 generations to 1994. 2 of the 269 devices in its family, counting itself, have a Class I recall. It has been recalled once.

Decided: Nov 26, 2013
Review: 153 days
Class: Class II
Product code: DRG
Recalls: 1
Predicates: 19

Its longest line of descent runs back 33 generations to K941811 (1994). 268 ancestors in all, the oldest K822695 (1982). No later device cites it as a predicate yet. 2 of the 269 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 33 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
29 generations between
3 generations backK110622 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · Recalled
2 generations backK113657 Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH · 2012
1 generation backK122439 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2012 · Recalled
This deviceK131913 Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2013

Show all 33 generations

Root · 33 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
32 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
31 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
30 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
29 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
28 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
27 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
26 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
25 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
24 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
23 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
22 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
21 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
20 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
19 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
18 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
17 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
16 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
15 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
14 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
13 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
12 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
11 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
10 generations backK061610 Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
9 generations backK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006
8 generations backK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
7 generations backK083517 Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · Recalled
6 generations backK091927 Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
5 generations backK100939 Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
4 generations backK101449 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
3 generations backK110622 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · Recalled
2 generations backK113657 Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH · 2012
1 generation backK122439 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2012 · Recalled
This deviceK131913 Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2013

Class I recalls in this family

K031187 Heartstart MRX, Model M3535A2 generations back · 2003
K970209 Capnocheck Plus6 generations back · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−33	K941811	HP M1175A, M1176A, Component Monitoring System	Hewlett-Packard Co.	1994	—
−32	K960934	HP M1205A Omnicare Component Monitor System Model 24	Hewlett-Packard Co.	1996	—
−31	K981376	Hewlett-Packard M1205A Viridia 24 CT	Hewlett-Packard Co.	1999	—
−30	K990125	HP Viridia Component Monitoring System, Model Rev. K	Hewlett-Packard GmbH	1999	—
−29	K990972	HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…	Hewlett-Packard GmbH	1999	—
−28	K013199	Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…	Philips Medical Systems, Inc.	2001	—
−27	K020531	Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…	Philips Medical Systems	2002	—
−26	K021778	Philips Component Compact Monitor, Release a.04, Model #M1275B	Philips Medical Systems	2002	—
−25	K023871	M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…	Philips Medical Systems	2002	—
−24	K030038	Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…	Philips Medical Systems, Inc.	2003	—
−23	K031481	The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20	Philips Medizin Systeme Boblingen GmbH	2003	—
−22	K032858	The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…	Philips Medizin Systeme Boblingen GmbH	2003	—
−21	K040304	Philips Intellivue Patient Monitor, Models MP40 & MP50	Philips Medizin Systeme Boeblingen GmbH	2004	—
−20	K041235	Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors	Philips Medizin Systeme Boeblingen GmbH	2004	—
−19	K042845	The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…	Philips Medizin Systeme Boblingen GmbH	2004	—
−18	K050141	The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…	Philips Medizin Systeme Boeblingen GmbH	2005	—
−17	K050762	Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…	Philips Medizin Systeme Boeblingen GmbH	2005	—
−16	K051106	The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…	Philips Medizin Systeme Boeblingen GmbH	2005	—
−15	K052801	Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50…	Philips Medizin Systeme Boeblingen GmbH	2005	—
−14	K053522	Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors…	Philips Medizin Systeme Boeblingen GmbH	2006	—
−13	K060221	The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue…	Philips Medizin Systeme Boeblingen GmbH	2006	—
−12	K060541	The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient…	Philips Medizin Systeme Boblingen GmbH	2006	2
−11	K061052	The Philips Intellivue Patient Monitors, Models…	Philips Medical Systems North America, Inc.	2006	—
−10	K061610	Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…	Philips Medizin Systeme Boeblingen GmbH	2006	—
−9	K063315	Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80…	Philips Medizin Systeme Boeblingen GmbH	2006	—
−8	K071426	MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2007	—
−7	K083517	Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2009	2
−6	K091927	Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2009	—
−5	K100939	Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2010	—
−4	K101449	Intellivue Patient Monitor	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2010	—
−3	K110622	Intellivue Patient Monitor	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2011	2
−2	K113657	Intellivue Patient Monitor	Philips Medizin Systeme Boblingen GmbH	2012	—
−1	K122439	Intellivue Patient Monitor	Philips Medizin Systeme Boeblingen GmbH	2012	4
0 (this device)	K131913	Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors…	Philips Medizin Systeme Boeblingen GmbH	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1982	1	0
1985	2	0
1986	2	0
1987	1	0
1989	5	0
1990	8	0
1991	10	0
1992	7	0
1993	7	0
1994	2	0
1995	9	0
1996	10	0
1997	9	1
1998	17	0
1999	16	0
2000	20	0
2001	10	0
2002	16	0
2003	14	1
2004	19	0
2005	13	0
2006	10	0
2007	6	0
2008	4	0
2009	5	0
2010	7	0
2011	2	0
2012	2	0
2013	1	0

FIG. 1 — Lineage of K131913, 1994–2013Source: 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 DRG device

#1 K223711 ANNE Onescore 20.8 · 11 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? (19)

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
*	K101600	Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue… Summary page 3 …iVue CIL SpO 2 Pod and CL NBP Pod. software Rev. 8.02, are substantially equivalent to the previously cleared IntelliVue CL SpO 2 Pod and CL NBP Pod marketed pursuant to K 10 1600 and KI 111905. With respect to the local attended monitoring feature the modified IntelliVue CL SpO2 Pod and CL NBP Pod are subst…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2010	—
*	K111905	Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215… Summary page 3 …d and CL NBP Pod. software Rev. 8.02, are substantially equivalent to the previously cleared IntelliVue CL SpO 2 Pod and CL NBP Pod marketed pursuant to K 10 1600 and KI 111905. With respect to the local attended monitoring feature the modified IntelliVue CL SpO2 Pod and CL NBP Pod are substantially equiv…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2011	—
*	K122223	New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment… Summary page 3 …modified IntelliVue CL SpO2 Pod and CL NBP Pod are substantially equivalent to the Philips IntelliVue X2 Multi-Measurement Module software Rev. J.07 marketed pursuant to K 1222231. K122439. K 120366, KI 13441, KI 13657. KI 110622. K 102562, K0835 17. K082633. K072070, and K07 1426. The new Philips air hose…	Philips Medizin Systeme Boeblingen GmbH	2013	—
*	K122439	Intellivue Patient Monitor Summary page 3 …telliVue CL SpO2 Pod and CL NBP Pod are substantially equivalent to the Philips IntelliVue X2 Multi-Measurement Module software Rev. J.07 marketed pursuant to K 1222231. K122439. K 120366, KI 13441, KI 13657. KI 110622. K 102562, K0835 17. K082633. K072070, and K07 1426. The new Philips air hose Mobile CL…	Philips Medizin Systeme Boeblingen GmbH	2012	4
*	K120366	Intellivue Patient Monitor Summary page 3 …CL SpO2 Pod and CL NBP Pod are substantially equivalent to the Philips IntelliVue X2 Multi-Measurement Module software Rev. J.07 marketed pursuant to K 1222231. K122439. K 120366, KI 13441, KI 13657. KI 110622. K 102562, K0835 17. K082633. K072070, and K07 1426. The new Philips air hose Mobile CL Air Hose-…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2012	—
*	K113441	Physiological Monitor, Patient Monitor Summary page 3 ….20, are substantially equivalent to the previously cleared IntelliVue Patient Monitors MP5. MP5T, and MP5SC marketed pursuant to K 122439. K 122223, K 120366, K 113657. K 11344 1.K110622, K102562, K(091395. K0835117, K(083228.1K082633. K081793. K(07 1426, K063725, and K062392. 4. Description of the device…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2012	1
*	K113657	Intellivue Patient Monitor Summary page 3 …re Rev. i1.20, are substantially equivalent to the previously cleared IntelliVue Patient Monitors MP5. MP5T, and MP5SC marketed pursuant to K 122439. K 122223, K 120366, K 113657. K 11344 1.K110622, K102562, K(091395. K0835117, K(083228.1K082633. K081793. K(07 1426, K063725, and K062392. 4. Description of…	Philips Medizin Systeme Boblingen GmbH	2012	—
*	K110622	Intellivue Patient Monitor Summary page 3 …ubstantially equivalent to the previously cleared IntelliVue Patient Monitors MP5. MP5T, and MP5SC marketed pursuant to K 122439. K 122223, K 120366, K 113657. K 11344 1.K110622, K102562, K(091395. K0835117, K(083228.1K082633. K081793. K(07 1426, K063725, and K062392. 4. Description of the devices The I…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2011	2
*	K102562	Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60… Summary page 3 …lly equivalent to the Philips IntelliVue X2 Multi-Measurement Module software Rev. J.07 marketed pursuant to K 1222231. K122439. K 120366, KI 13441, KI 13657. KI 110622. K 102562, K0835 17. K082633. K072070, and K07 1426. The new Philips air hose Mobile CL Air Hose-Bayonet Connector is substantially equiva…	Philips Medizin Systeme Boblingen GmbH	2010	—
*	K083517	Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80… Summary page 3 …lent to the Philips IntelliVue X2 Multi-Measurement Module software Rev. J.07 marketed pursuant to K 1222231. K122439. K 120366, KI 13441, KI 13657. KI 110622. K 102562, K0835 17. K082633. K072070, and K07 1426. The new Philips air hose Mobile CL Air Hose-Bayonet Connector is substantially equivalent to th…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2009	2
*	K082633	Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50… Summary page 3 …e Philips IntelliVue X2 Multi-Measurement Module software Rev. J.07 marketed pursuant to K 1222231. K122439. K 120366, KI 13441, KI 13657. KI 110622. K 102562, K0835 17. K082633. K072070, and K07 1426. The new Philips air hose Mobile CL Air Hose-Bayonet Connector is substantially equivalent to the previou…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2008	3
*	K072070	Philips MP2 and X2 Intellivue Patient Monitors Summary page 3 …IntelliVue X2 Multi-Measurement Module software Rev. J.07 marketed pursuant to K 1222231. K122439. K 120366, KI 13441, KI 13657. KI 110622. K 102562, K0835 17. K082633. K072070, and K07 1426. The new Philips air hose Mobile CL Air Hose-Bayonet Connector is substantially equivalent to the previously clear…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2007	—
*	K071426	MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient… Summary page 3 …2 Multi-Measurement Module software Rev. J.07 marketed pursuant to K 1222231. K122439. K 120366, KI 13441, KI 13657. KI 110622. K 102562, K0835 17. K082633. K072070, and K07 1426. The new Philips air hose Mobile CL Air Hose-Bayonet Connector is substantially equivalent to the previously cleared Philips air…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2007	—
*	K052707	M3046B Compact Portable Patient Monitors Summary page 3 …tor is substantially equivalent to the previously cleared Philips air hoses Mobile CL Extension Air Hose marketed pursuant to K 10 1600 and MlI 598B marketed pursuant to K052707. The modified Philips IntelliVue Patient Monitors MP5. MP5T. and MP5SC, software Rev. i1.20, are substantially equivalent to the…	Philips Medical Systems	2005	1
*	K091395	MP5 Intellivue Patient Monitor Summary page 3 …ent to the previously cleared IntelliVue Patient Monitors MP5. MP5T, and MP5SC marketed pursuant to K 122439. K 122223, K 120366, K 113657. K 11344 1.K110622, K102562, K(091395. K0835117, K(083228.1K082633. K081793. K(07 1426, K063725, and K062392. 4. Description of the devices The IntelliVue CL SpO2 P…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2009	—
*	K083228	Philips Intellivue MP5 Patient Monitor Summary page 3 …y cleared IntelliVue Patient Monitors MP5. MP5T, and MP5SC marketed pursuant to K 122439. K 122223, K 120366, K 113657. K 11344 1.K110622, K102562, K(091395. K0835117, K(083228.1K082633. K081793. K(07 1426, K063725, and K062392. 4. Description of the devices The IntelliVue CL SpO2 Pod isa small, batter…	Philips Medizin Systeme Boblingen GmbH	2008	—
*	K081793	Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry… Summary page 3 …Vue Patient Monitors MP5. MP5T, and MP5SC marketed pursuant to K 122439. K 122223, K 120366, K 113657. K 11344 1.K110622, K102562, K(091395. K0835117, K(083228.1K082633. K081793. K(07 1426, K063725, and K062392. 4. Description of the devices The IntelliVue CL SpO2 Pod isa small, battery powered. wrist w…	Philips Medizin Systeme Boeblingen GmbH	2008	—
*	K063725	MP5 Intellivue Patient Monitor Summary page 3 …MP5. MP5T, and MP5SC marketed pursuant to K 122439. K 122223, K 120366, K 113657. K 11344 1.K110622, K102562, K(091395. K0835117, K(083228.1K082633. K081793. K(07 1426, K063725, and K062392. 4. Description of the devices The IntelliVue CL SpO2 Pod isa small, battery powered. wrist worn pulse oximeter d…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2007	—
*	K062392	Philips MP5 Intellivue Patient Monitor Summary page 3 …nd MP5SC marketed pursuant to K 122439. K 122223, K 120366, K 113657. K 11344 1.K110622, K102562, K(091395. K0835117, K(083228.1K082633. K081793. K(07 1426, K063725, and K062392. 4. Description of the devices The IntelliVue CL SpO2 Pod isa small, battery powered. wrist worn pulse oximeter device for ca…	Philips Medizin Systeme Boeblingen GmbH	2006	—

Also cleared against K101600: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 3, 2014	Class II	Z-0104-2015	Software Design Change	Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped

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 · 2 generations back · ◆ 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 19 years and passes through 8 companies; a new generation was cleared every 4 months on median.
45 of the 268 ancestors have a recall of any class; 2 have a Class I recall.
1 other device also cites its predicate K101600.

How does its category compare?

All DRG devices

DRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · DRG

3in 2025

2007high 13 (2009) · low 2 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRG

127in 2025

2007high 287 (2022) · low 63 (2007)2026

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

Recalls per year · DRG

3in 2007

2007high 3 (2007) · low 0 (2008)2026

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

Adverse event reports per year · DRG

52in 2025

2007high 484 (2017) · low 5 (2009)2025

MAUDE reports naming product code DRG, 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	6	63	3	14
2008	5	74	0	9
2009	13	94	0	5
2010	10	68	0	13
2011	9	104	0	12
2012	12	103	0	9
2013	13	146	0	13
2014	10	177	0	97
2015	2	—	0	131
2016	2	—	0	182
2017	7	98	0	484
2018	6	220	0	166
2019	5	122	0	70
2020	6	159	0	82
2021	2	—	0	107
2022	6	287	0	43
2023	4	212	0	19
2024	3	125	0	26
2025	3	127	0	52
2026	2	—	1	—

What is it indicated for?

IntelliVue CL SpO2 Pod: The IntelliVue CL SPO 2 Pod is indicated for use by health care professionals whenever there is a need for acquisition or monitoring of physiological patient parameters SpO2 and pulse rate wirelessly. The intended use of the IntelliVue CL SpO2 Pod when used together with a patient monitor or with a telemetry system transceiver is for monitoring, and recording of. and to generate alarms for, arterial oxygen saturation and pulse…

Read the full statement (744 words)

IntelliVue CL SpO2 Pod:

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

The intended use of the IntelliVue CL SpO2 Pod when used together with a patient monitor or with a telemetry system transceiver is for monitoring, and recording of. and to generate alarms for, arterial oxygen saturation and pulse rate of adult and pediatric patients.

The IntelliVue CL SP0 2 Pod is also intended for local attended monitoring of. and to generate alarms for, arterial oxygen saturation and pulse rate of adult and pediatric patients.

The IntelliVue CL Sp 0 2 Pod is also intended for acquisition of arterial oxygen saturation and pulse rate data of adult and pediatric patients for a clinical information management system.

The IntelliVue CL SPO2 Pod is intended for use by health care professionals inside hospitals. It is not intended for home use. It is not a therapeutic device.

Local attended monitoring refers to situations where clinical staff is close to the patient such that acoustic alarming of the IntelliVue CL SPO2 Pod will be noticed. Example: In-hospital transport of a patient by hospital staff to a procedure room.

IntelliVue CL NBP Pod:

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

The intended use of the IntelliVue CL NBP Pod when used together with a patient monitor or with a telemietry system transceiver is for monitoring and recording of, and to generate alarms for, systolic, diastolic, and mean pressure, and to measure pulse rate of adult and pediatric patients.

The IntelliVue CL NBP Pod is also intended for local attended monitoring of. and to generate alarms for, systolic, diastolic, and mean pressure, and to measure pulse rate of adult and pediatric patients.

The IntelliVue CL NBP Pod is also intended for acquisition of systolic, diastolic, and mean pressure and pulse rate data of adult and pediatric patients for a clinical information management system.

The IntelliVue CL NBP Pod is intended for use by health care professionals inside hospitals. It is not intended for home use. It is not a therapeutic device.

Local attended monitoring refers to situations where clinical staff is close to the patient such that acoustic alarming of the IntelliVue CL NBP Pod will be noticed. Example: In-hospital transport of a patient by hospital staff to a procedure room.

IntelliVue Patient Monitors MP5, MP5T, and MP5SC:

The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.

The MI'S. MPSSC and MP5T monitors are also intended for use during patient transport inside the hospital environment: only the MI'S monitor is for use during patient transport outside of the hospital environment. The MI'S, MPSSC and MPST when used with the TP-x484 1A/TRx4851IA IntelliVue Telemetry System Transceiver or with the IntelliVue Cableless Measurement Devices, are intended for use in a hospital environment and during patient transport inside the hospital environment.

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

The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMIECI 11).

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

The Predictive Temperature unit is intended for use with adult and pediatric patients in a hospital environment.

The SSC Sepsis Protocol, in the Protocol Watch clinical decision support tool, is intended for use with adult patients only.

The Integrated Pulmonary Index (MP)is intended for use with adult and pediatric (I to 12 years) patients only. Thle IPI is an adjunct to and not intended to replace vital sign monitoring.

The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K131913 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131913: Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T, MP5SC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131913

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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