510(k) · Cleared

Cleared

Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90

K063315510(k) SpecialCleared Nov 20, 200618-day reviewClass II21 CFR 870.1025

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 · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Nov 20, 2006 as substantially equivalent to K021778 (Philips Medical Systems, 2002) and 16 other predicates after an 18-day review. Its family tree reaches back 24 generations to 1994. 154 later devices descend from it.

Decided: Nov 20, 2006
Review: 18 days
Class: Class II
Product code: MHX
Recalls: None
Predicates: 17

Its longest line of descent runs back 24 generations to K941811 (1994). 152 ancestors in all, the oldest K844187 (1985). 154 later devices descend from it, 16 citing it directly.

By dateBy generation

Root · 24 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
20 generations between
3 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
2 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
1 generation backK061610 Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
This deviceK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006
Descendant · cites it directly · 151 of its ownK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
Descendant · cites it directly · 127 of its ownK082633 Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2008 · Recalled
Descendant · cites it directly · 125 of its ownK083517 Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · Recalled
Descendant · cites it directly · 124 of its ownK091927 Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
Descendant · 2 generations on · 123 of its ownK100939 Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010

Show all 24 generations

Root · 24 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
23 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
22 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
21 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
20 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
19 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
18 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
17 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
16 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
15 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
14 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
13 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
12 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
11 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
10 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
9 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
8 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
7 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
6 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
5 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
4 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
3 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
2 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
1 generation backK061610 Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
This deviceK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006

Showing 5 of 154 descendants. See all descendants

Descendants cleared per year

2007high 15 (2025) · low 2 (2007)2026

Most influential descendants

Showing 5 of 154 · See all

K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007 · cites it directly151descendants
K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2008 · cites it directly127descendants
K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · cites it directly125descendants
K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · cites it directly124descendants
K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010 · 2 generations on123descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−24	K941811	HP M1175A, M1176A, Component Monitoring System	Hewlett-Packard Co.	1994	—
−23	K960934	HP M1205A Omnicare Component Monitor System Model 24	Hewlett-Packard Co.	1996	—
−22	K981376	Hewlett-Packard M1205A Viridia 24 CT	Hewlett-Packard Co.	1999	—
−21	K990125	HP Viridia Component Monitoring System, Model Rev. K	Hewlett-Packard GmbH	1999	—
−20	K990972	HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…	Hewlett-Packard GmbH	1999	—
−19	K013199	Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…	Philips Medical Systems, Inc.	2001	—
−18	K020531	Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…	Philips Medical Systems	2002	—
−17	K021778	Philips Component Compact Monitor, Release a.04, Model #M1275B	Philips Medical Systems	2002	—
−16	K023871	M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…	Philips Medical Systems	2002	—
−15	K030038	Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…	Philips Medical Systems, Inc.	2003	—
−14	K031481	The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20	Philips Medizin Systeme Boblingen GmbH	2003	—
−13	K032858	The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…	Philips Medizin Systeme Boblingen GmbH	2003	—
−12	K040304	Philips Intellivue Patient Monitor, Models MP40 & MP50	Philips Medizin Systeme Boeblingen GmbH	2004	—
−11	K041235	Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors	Philips Medizin Systeme Boeblingen GmbH	2004	—
−10	K042845	The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…	Philips Medizin Systeme Boblingen GmbH	2004	—
−9	K050141	The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…	Philips Medizin Systeme Boeblingen GmbH	2005	—
−8	K050762	Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…	Philips Medizin Systeme Boeblingen GmbH	2005	—
−7	K051106	The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…	Philips Medizin Systeme Boeblingen GmbH	2005	—
−6	K052801	Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50…	Philips Medizin Systeme Boeblingen GmbH	2005	—
−5	K053522	Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors…	Philips Medizin Systeme Boeblingen GmbH	2006	—
−4	K060221	The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue…	Philips Medizin Systeme Boeblingen GmbH	2006	—
−3	K060541	The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient…	Philips Medizin Systeme Boblingen GmbH	2006	2
−2	K061052	The Philips Intellivue Patient Monitors, Models…	Philips Medical Systems North America, Inc.	2006	—
−1	K061610	Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…	Philips Medizin Systeme Boeblingen GmbH	2006	—
0 (this device)	K063315	Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80…	Philips Medizin Systeme Boeblingen GmbH	2006	—
+1	K071426	MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2007	—
+1	K082633	Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2008	3
+1	K083517	Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2009	2
+1	K091927	Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2009	—
+2	K100939	Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1985	1	0
1987	1	0
1989	2	0
1990	5	0
1991	6	0
1992	6	0
1993	5	0
1994	2	0
1995	5	0
1996	8	0
1997	7	0
1998	13	0
1999	9	0
2000	19	0
2001	5	0
2002	11	0
2003	8	0
2004	11	0
2005	1	0
2006	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	2	0
2008	2	0
2009	5	0
2010	4	0
2011	6	0
2012	8	0
2013	9	0
2014	9	0
2015	6	0
2016	9	0
2017	9	0
2018	10	0
2019	6	0
2020	6	0
2021	6	0
2022	13	0
2023	11	0
2024	11	0
2025	15	0
2026	7	0

FIG. 1 — Lineage of K063315, 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.

Planning a device in MHX? 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 MHX device

#1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 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? (17)

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
*	K021778	Philips Component Compact Monitor, Release a.04, Model #M1275B Summary page 2 …Electroencephalogram Signal 3. The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to, K021778, K030038, K032858, K033513, K040304, K041235, K042845, K050141, K050762, K051106, K052801, K053522, K060221, K060541, K0610…	Philips Medical Systems	2002	—
*	K030038	Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185… Summary page 2 …Electroencephalogram Signal 3. The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to, K021778, K030038, K032858, K033513, K040304, K041235, K042845, K050141, K050762, K051106, K052801, K053522, K060221, K060541, K061052, K0616…	Philips Medical Systems, Inc.	2003	—
*	K032858	The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O. Summary page 2 …Electroencephalogram Signal 3. The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to, K021778, K030038, K032858, K033513, K040304, K041235, K042845, K050141, K050762, K051106, K052801, K053522, K060221, K060541, K061052, K061610 and K0…	Philips Medizin Systeme Boblingen GmbH	2003	—
*	K033513	Easi Ecg Algorithm Summary page 2 …roencephalogram Signal 3. The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to, K021778, K030038, K032858, K033513, K040304, K041235, K042845, K050141, K050762, K051106, K052801, K053522, K060221, K060541, K061052, K061610 and K062283 4.…	Philips Medical Systems	2004	—
*	K040304	Philips Intellivue Patient Monitor, Models MP40 & MP50 Summary page 2 …logram Signal 3. The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to, K021778, K030038, K032858, K033513, K040304, K041235, K042845, K050141, K050762, K051106, K052801, K053522, K060221, K060541, K061052, K061610 and K062283 4. The mo…	Philips Medizin Systeme Boeblingen GmbH	2004	—
*	K041235	Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors Summary page 2 …gnal 3. The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to, K021778, K030038, K032858, K033513, K040304, K041235, K042845, K050141, K050762, K051106, K052801, K053522, K060221, K060541, K061052, K061610 and K062283 4. The modificatio…	Philips Medizin Systeme Boeblingen GmbH	2004	—
*	K042845	The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors Summary page 2 …modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to, K021778, K030038, K032858, K033513, K040304, K041235, K042845, K050141, K050762, K051106, K052801, K053522, K060221, K060541, K061052, K061610 and K062283 4. The modification is the int…	Philips Medizin Systeme Boblingen GmbH	2004	—
*	K050141	The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient Monitors Summary page 2 …devices are substantially equivalent to previously cleared Philips devices marketed pursuant to, K021778, K030038, K032858, K033513, K040304, K041235, K042845, K050141, K050762, K051106, K052801, K053522, K060221, K060541, K061052, K061610 and K062283 4. The modification is the introduction…	Philips Medizin Systeme Boeblingen GmbH	2005	—
*	K050762	Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Summary page 2 …are substantially equivalent to previously cleared Philips devices marketed pursuant to, K021778, K030038, K032858, K033513, K040304, K041235, K042845, K050141, K050762, K051106, K052801, K053522, K060221, K060541, K061052, K061610 and K062283 4. The modification is the introduction of softw…	Philips Medizin Systeme Boeblingen GmbH	2005	—
*	K051106	The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors Summary page 2 …antially equivalent to previously cleared Philips devices marketed pursuant to, K021778, K030038, K032858, K033513, K040304, K041235, K042845, K050141, K050762, K051106, K052801, K053522, K060221, K060541, K061052, K061610 and K062283 4. The modification is the introduction of software Relea…	Philips Medizin Systeme Boeblingen GmbH	2005	—
*	K052801	Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60… Summary page 2 …equivalent to previously cleared Philips devices marketed pursuant to, K021778, K030038, K032858, K033513, K040304, K041235, K042845, K050141, K050762, K051106, K052801, K053522, K060221, K060541, K061052, K061610 and K062283 4. The modification is the introduction of software Release E.03…	Philips Medizin Systeme Boeblingen GmbH	2005	—
*	K053522	Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00 Summary page 2 …t to previously cleared Philips devices marketed pursuant to, K021778, K030038, K032858, K033513, K040304, K041235, K042845, K050141, K050762, K051106, K052801, K053522, K060221, K060541, K061052, K061610 and K062283 4. The modification is the introduction of software Release E.03 for t…	Philips Medizin Systeme Boeblingen GmbH	2006	—
*	K060221	The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient… Summary page 2 …iously cleared Philips devices marketed pursuant to, K021778, K030038, K032858, K033513, K040304, K041235, K042845, K050141, K050762, K051106, K052801, K053522, K060221, K060541, K061052, K061610 and K062283 4. The modification is the introduction of software Release E.03 for the IntelliVu…	Philips Medizin Systeme Boeblingen GmbH	2006	—
*	K060541	The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors Summary page 2 …eared Philips devices marketed pursuant to, K021778, K030038, K032858, K033513, K040304, K041235, K042845, K050141, K050762, K051106, K052801, K053522, K060221, K060541, K061052, K061610 and K062283 4. The modification is the introduction of software Release E.03 for the IntelliVue patient…	Philips Medizin Systeme Boblingen GmbH	2006	2
*	K061052	The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90 Summary page 2 …lips devices marketed pursuant to, K021778, K030038, K032858, K033513, K040304, K041235, K042845, K050141, K050762, K051106, K052801, K053522, K060221, K060541, K061052, K061610 and K062283 4. The modification is the introduction of software Release E.03 for the IntelliVue patient monitor…	Philips Medical Systems North America, Inc.	2006	—
*	K061610	Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient… Summary page 2 …ces marketed pursuant to, K021778, K030038, K032858, K033513, K040304, K041235, K042845, K050141, K050762, K051106, K052801, K053522, K060221, K060541, K061052, K061610 and K062283 4. The modification is the introduction of software Release E.03 for the IntelliVue patient monitor devices.…	Philips Medizin Systeme Boeblingen GmbH	2006	—
*	K062283	The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient Monitors Summary page 2 …pursuant to, K021778, K030038, K032858, K033513, K040304, K041235, K042845, K050141, K050762, K051106, K052801, K053522, K060221, K060541, K061052, K061610 and K062283 4. The modification is the introduction of software Release E.03 for the IntelliVue patient monitor devices. 5. The mo…	Philips Medical Systems North America, Inc.	2006	—

Also cleared against K021778: 30 other devices →

What descends from it? (154)

See all 154

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

Number	Device	Applicant	Decided	Descendants
K071426	MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2007	151
K082633	Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2008	127
K083517	Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2009	125
K091927	Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2009	124
K102562	Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…	Philips Medizin Systeme Boblingen GmbH	2010	103
K082583	Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50, MP60, MP70, MP80…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2009	94
K110622	Intellivue Patient Monitor	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2011	90
K113657	Intellivue Patient Monitor	Philips Medizin Systeme Boblingen GmbH	2012	81
K113441	Physiological Monitor, Patient Monitor	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2012	78
K120366	Intellivue Patient Monitor	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2012	46

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 12 years and passes through 7 companies; a new generation was cleared every 3 months on median.
15 of the 152 ancestors have a recall of any class.
Of its descendants, K071426 (Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, 2007) has gone furthest, with 151 descendants of its own.
30 other devices also cite its predicate K021778.

How does its category compare?

All MHX devices

MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MHX

8in 2025

2007high 21 (2013) · low 5 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHX

192in 2025

2007high 248 (2014) · low 57 (2009)2026

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

Recalls per year · MHX

21so far in 2026, the most since 2007

2007high 21 (2026) · low 0 (2020)2026

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

Adverse event reports per year · MHX

3,761in 2025

2007high 3,761 (2025) · low 131 (2007)2025

MAUDE reports naming product code MHX, 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	15	96	3	131
2008	16	58	2	232
2009	13	57	7	382
2010	20	90	13	955
2011	12	81	16	949
2012	16	88	11	676
2013	21	120	14	1,997
2014	13	248	6	1,609
2015	14	203	5	1,284
2016	13	149	7	1,105
2017	14	134	6	1,115
2018	11	203	12	2,157
2019	7	243	6	1,462
2020	11	196	0	1,714
2021	5	195	0	2,423
2022	15	189	6	1,470
2023	8	229	3	2,254
2024	5	181	3	2,814
2025	8	192	15	3,761
2026	14	205	21	—

What is it indicated for?

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 healthcare facilities. The MP20, MP30, MP40 and MP50 are additionally intended for use in transport situations within healthcare facilities.

ST Segment monitoring is restricted to adult patients only.

The transcutaneous gas measurement (tcpO2 / tcpCO2) is restricted to neonatal patients only.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K063315 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063315: Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063315

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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