510(k) · Cleared

Cleared

Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00

K053522510(k) SpecialCleared Jan 10, 200622-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 Jan 10, 2006 as substantially equivalent to K014159 (Philips Medical Systems, Inc., 2002) and 15 other predicates after a 22-day review. Its family tree reaches back 19 generations to 1994. 233 later devices descend from it.

Decided: Jan 10, 2006
Review: 22 days
Class: Class II
Product code: MHX
Recalls: None
Predicates: 18

Its longest line of descent runs back 19 generations to K941811 (1994). 126 ancestors in all, the oldest K872781 (1987). 233 later devices descend from it, 25 citing it directly.

By dateBy generation

Root · 19 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
15 generations between
3 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
2 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
1 generation backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
This deviceK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
Descendant · cites it directly · 222 of its ownK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
Descendant · cites it directly · 221 of its ownK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
Descendant · cites it directly · 211 of its ownK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
Descendant · cites it directly · 188 of its ownK062283 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90…Philips Medical Systems North America, Inc. · 2006
Descendant · cites it directly · 176 of its ownK062392 Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2006

Show all 19 generations

Root · 19 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
18 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
17 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
16 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
15 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
14 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
13 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
12 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
11 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
10 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
9 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
8 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
7 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
6 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
5 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
4 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
3 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
2 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
1 generation backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
This deviceK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006

Showing 5 of 233 descendants. See all descendants

Descendants cleared per year

2006high 21 (2023) · low 3 (2007)2026

Most influential descendants

Showing 5 of 233 · See all

K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006 · cites it directly222descendants
K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsPhilips Medizin Systeme Boblingen GmbH · 2006 · cites it directly221descendants
K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc. · 2006 · cites it directly211descendants
K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsPhilips Medical Systems North America, Inc. · 2006 · cites it directly188descendants
K062392Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2006 · cites it directly176descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−19	K941811	HP M1175A, M1176A, Component Monitoring System	Hewlett-Packard Co.	1994	—
−18	K960934	HP M1205A Omnicare Component Monitor System Model 24	Hewlett-Packard Co.	1996	—
−17	K981376	Hewlett-Packard M1205A Viridia 24 CT	Hewlett-Packard Co.	1999	—
−16	K990125	HP Viridia Component Monitoring System, Model Rev. K	Hewlett-Packard GmbH	1999	—
−15	K990972	HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…	Hewlett-Packard GmbH	1999	—
−14	K013199	Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…	Philips Medical Systems, Inc.	2001	—
−13	K020531	Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…	Philips Medical Systems	2002	—
−12	K021778	Philips Component Compact Monitor, Release a.04, Model #M1275B	Philips Medical Systems	2002	—
−11	K023871	M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…	Philips Medical Systems	2002	—
−10	K030038	Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…	Philips Medical Systems, Inc.	2003	—
−9	K031481	The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20	Philips Medizin Systeme Boblingen GmbH	2003	—
−8	K032858	The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…	Philips Medizin Systeme Boblingen GmbH	2003	—
−7	K040304	Philips Intellivue Patient Monitor, Models MP40 & MP50	Philips Medizin Systeme Boeblingen GmbH	2004	—
−6	K041235	Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors	Philips Medizin Systeme Boeblingen GmbH	2004	—
−5	K042845	The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…	Philips Medizin Systeme Boblingen GmbH	2004	—
−4	K050141	The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…	Philips Medizin Systeme Boeblingen GmbH	2005	—
−3	K050762	Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…	Philips Medizin Systeme Boeblingen GmbH	2005	—
−2	K051106	The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…	Philips Medizin Systeme Boeblingen GmbH	2005	—
−1	K052801	Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50…	Philips Medizin Systeme Boeblingen GmbH	2005	—
0 (this device)	K053522	Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors…	Philips Medizin Systeme Boeblingen GmbH	2006	—
+1	K060221	The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue…	Philips Medizin Systeme Boeblingen GmbH	2006	—
+1	K060541	The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient…	Philips Medizin Systeme Boblingen GmbH	2006	2
+1	K061052	The Philips Intellivue Patient Monitors, Models…	Philips Medical Systems North America, Inc.	2006	—
+1	K062283	The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient…	Philips Medical Systems North America, Inc.	2006	—
+1	K062392	Philips MP5 Intellivue Patient Monitor	Philips Medizin Systeme Boeblingen GmbH	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
1989	2	0
1990	5	0
1991	6	0
1992	6	0
1993	5	0
1994	2	0
1995	4	0
1996	6	0
1997	6	0
1998	13	0
1999	9	0
2000	16	0
2001	5	0
2002	9	0
2003	5	0
2004	7	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	8	0
2007	3	0
2008	5	0
2009	5	0
2010	6	0
2011	8	0
2012	9	0
2013	12	0
2014	10	0
2015	7	0
2016	11	0
2017	12	0
2018	14	0
2019	10	0
2020	9	0
2021	13	0
2022	18	0
2023	21	0
2024	18	0
2025	21	0
2026	13	0

FIG. 1 — Lineage of K053522, 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? (18)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K014159	Phillips M1175A/76A/77A Component Monitoring System; Phillips V24/V26 Patient Monitor Summary page 2 …_ Electroencephalogram Signal 3. The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, 050762 and K051106, K05280…	Philips Medical Systems, Inc.	2002	—
*	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 K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, 050762 and K051106, K052801 , and t…	Philips Medical Systems	2002	—
*	K030038	Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185… Summary page 2 …lectroencephalogram Signal 3. The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, 050762 and K051106, K052801 , and to Respiro…	Philips Medical Systems, Inc.	2003	—
*	K032858	The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O. Summary page 2 …ephalogram Signal 3. The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, 050762 and K051106, K052801 , and to Respironics Nova…	Philips Medizin Systeme Boblingen GmbH	2003	—
*	K040304	Philips Intellivue Patient Monitor, Models MP40 & MP50 Summary page 2 …m Signal 3. The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, 050762 and K051106, K052801 , and to Respironics Novametrix Fl…	Philips Medizin Systeme Boeblingen GmbH	2004	—
Kept off the family tree	K040183	FDA’s K040183 is BISX Our reading of the summary gave K040183, FDA’s number for BISX (Aspect Medical Systems, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Philips devices”. Kept off the family tree. Summary page 2 …3. The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, 050762 and K051106, K052801 , and to Respironics Novametrix Flow Sensor…	Aspect Medical Systems, Inc.	2004	—
*	K040357	M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry… Summary page 2 …d devices are substantially equivalent to previously cleared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, 050762 and K051106, K052801 , and to Respironics Novametrix Flow Sensors "PN 6716.-…	Philips Medical Systems, Inc.	2004	—
*	K041235	Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors Summary page 2 …are substantially equivalent to previously cleared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, 050762 and K051106, K052801 , and to Respironics Novametrix Flow Sensors "PN 6716.-.6720" an…	Philips Medizin Systeme Boeblingen GmbH	2004	—
Kept off the family tree	K041741	FDA’s K041741 is M3290A Intellivue Information Center Software Release F.0 and M4840A Philips… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Philips Medical Systems, Inc.	2004	4
*	K042845	The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors Summary page 2 …y equivalent to previously cleared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, 050762 and K051106, K052801 , and to Respironics Novametrix Flow Sensors "PN 6716.-.6720" and Monitor Device…	Philips Medizin Systeme Boblingen GmbH	2004	—
*	K050141	The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient Monitors Summary page 2 …ent to previously cleared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, 050762 and K051106, K052801 , and to Respironics Novametrix Flow Sensors "PN 6716.-.6720" and Monitor Device "NICO, Mo…	Philips Medizin Systeme Boeblingen GmbH	2005	—
*	K050762	Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Summary page 2 …previously cleared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, 050762 and K051106, K052801 , and to Respironics Novametrix Flow Sensors "PN 6716.-.6720" and Monitor Device "NICO, Model 7300…	Philips Medizin Systeme Boeblingen GmbH	2005	—
*	K051106	The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors Summary page 2 …eared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, 050762 and K051106, K052801 , and to Respironics Novametrix Flow Sensors "PN 6716.-.6720" and Monitor Device "NICO, Model 7300" (K960831,…	Philips Medizin Systeme Boeblingen GmbH	2005	—
*	K052801	Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60… Summary page 2 …lips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, 050762 and K051106, K052801 , and to Respironics Novametrix Flow Sensors "PN 6716.-.6720" and Monitor Device "NICO, Model 7300" (K960831, K963380,…	Philips Medizin Systeme Boeblingen GmbH	2005	—
*	K960831	Ventrak RMMS 1550 Summary page 2 …K41741, K042845, K050141, 050762 and K051106, K052801 , and to Respironics Novametrix Flow Sensors "PN 6716.-.6720" and Monitor Device "NICO, Model 7300" (K960831, K963380, K982499, and K030886) 4. The modification is the introduction of Release D.00 software for the IntelliVue patie…	Novametrix Medical Systems, Inc.	1996	—
*	K963380	CO 2 Smo Plus Summary page 2 …042845, K050141, 050762 and K051106, K052801 , and to Respironics Novametrix Flow Sensors "PN 6716.-.6720" and Monitor Device "NICO, Model 7300" (K960831, K963380, K982499, and K030886) 4. The modification is the introduction of Release D.00 software for the IntelliVue patient monito…	Novametrix Medical Systems, Inc.	1997	3
*	K982499	Cosmo Plus with Nico, Model 8200 Summary page 2 …050141, 050762 and K051106, K052801 , and to Respironics Novametrix Flow Sensors "PN 6716.-.6720" and Monitor Device "NICO, Model 7300" (K960831, K963380, K982499, and K030886) 4. The modification is the introduction of Release D.00 software for the IntelliVue patient monitor devices…	Novametrix Medical Systems, Inc.	1998	1
*	K030886	Nico with Mars, Model 7300 Summary page 2 …2 and K051106, K052801 , and to Respironics Novametrix Flow Sensors "PN 6716.-.6720" and Monitor Device "NICO, Model 7300" (K960831, K963380, K982499, and K030886) 4. The modification is the introduction of Release D.00 software for the IntelliVue patient monitor devices, MP40, MP50,…	Respironics Novametrix, Inc.	2003	8

Also cleared against K014159: 9 other devices →

What descends from it? (233)

See all 233

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

Number	Device	Applicant	Decided	Descendants
K060221	The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…	Philips Medizin Systeme Boeblingen GmbH	2006	222
K060541	The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors	Philips Medizin Systeme Boblingen GmbH	2006	221
K061052	The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90	Philips Medical Systems North America, Inc.	2006	211
K062283	The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient Monitors	Philips Medical Systems North America, Inc.	2006	188
K062392	Philips MP5 Intellivue Patient Monitor	Philips Medizin Systeme Boeblingen GmbH	2006	176
K061610	Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…	Philips Medizin Systeme Boeblingen GmbH	2006	155
K063315	Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90	Philips Medizin Systeme Boeblingen GmbH	2006	154
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

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 6 companies; a new generation was cleared every 4 months on median.
10 of the 126 ancestors have a recall of any class.
Of its descendants, K060221 (Philips Medizin Systeme Boeblingen GmbH, 2006) has gone furthest, with 222 descendants of its own.
9 other devices also cite its predicate K014159.

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 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 as stated in the FDA summary.

https://510kreport.com/device/K053522 · printed Nov 4, 2026

Cite this page

510(k) Report. “K053522: Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053522

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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