510(k) · Cleared

Cleared

M3290A Intellivue Information Center Software Release E.1

K031403510(k) SpecialCleared May 30, 200325-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 Medical Systems, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on May 30, 2003 as substantially equivalent to K011093 (Agilent Technologies, Inc., 2001) after a 25-day review. Its family tree reaches back 1 generation to 2001. 263 later devices descend from it.

Decided: May 30, 2003
Review: 25 days
Class: Class II
Product code: MHX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011093 (2001). 263 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 1 generation backK011093 Agilent Information Center Software for M3150,M3151,M3153 and M3154Agilent Technologies, Inc. · 2001 · Recalled
This deviceK031403 M3290A Intellivue Information Center Software Release E.1Philips Medical Systems, Inc. · 2003
Descendant · cites it directly · 260 of its ownK040357 M3290A Intellivue Information Center Software Release F.O and the…Philips Medical Systems, Inc. · 2004
Descendant · 2 generations on · 252 of its ownK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
Descendant · 2 generations on · 251 of its ownK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
Descendant · 2 generations on · 250 of its ownK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
Descendant · 2 generations on · 249 of its ownK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005

Showing 5 of 263 descendants. See all descendants

Descendants cleared per year

2004high 21 (2023) · low 4 (2007)2026

Most influential descendants

Showing 5 of 263 · See all

K040357M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry…Philips Medical Systems, Inc. · 2004 · cites it directly260descendants
K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2004 · 2 generations on252descendants
K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boblingen GmbH · 2004 · 2 generations on251descendants
K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2005 · 2 generations on250descendants
K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH · 2005 · 2 generations on249descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011093	Agilent Information Center Software for M3150,M3151,M3153 and M3154	Agilent Technologies, Inc.	2001	4
0 (this device)	K031403	M3290A Intellivue Information Center Software Release E.1	Philips Medical Systems, Inc.	2003	—
+1	K040357	M3290A Intellivue Information Center Software Release F.O and the M4840A…	Philips Medical Systems, Inc.	2004	—
+2	K041235	Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors	Philips Medizin Systeme Boeblingen GmbH	2004	—
+2	K042845	The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…	Philips Medizin Systeme Boblingen GmbH	2004	—
+2	K050141	The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…	Philips Medizin Systeme Boeblingen GmbH	2005	—
+2	K050762	Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…	Philips Medizin Systeme Boeblingen GmbH	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	5	0
2005	8	0
2006	10	0
2007	4	0
2008	6	0
2009	5	0
2010	9	0
2011	10	0
2012	9	0
2013	13	0
2014	11	0
2015	8	0
2016	13	0
2017	12	0
2018	15	0
2019	10	0
2020	10	0
2021	13	0
2022	19	0
2023	21	0
2024	18	0
2025	21	0
2026	13	0

FIG. 1 — Lineage of K031403, 2001–2026Source: 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

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What was it cleared against? (1)

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
*	K011093	Agilent Information Center Software for M3150,M3151,M3153 and M3154 Summary page 1 …Phvsioloaical Monitors 3. The new device is substantially equivalent to the previously cleared IntelliVue Information Center Software cleared under K011093. 4. The modification is a change that provides different alert data export via the hospital LAN. 5. The new device has the s…	Agilent Technologies, Inc.	2001	4

Also cleared against K011093: 6 other devices →

What descends from it? (263)

See all 263

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

Number	Device	Applicant	Decided	Descendants
K040357	M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry…	Philips Medical Systems, Inc.	2004	260
K050742	M3290A Intellivue Information Center Software Release G.00	Philips Medical Systems	2005	16
K040955	M3290A Intellivue Information Center Software Release E.01 and Intellivue Clinical…	Philips Medical Systems, Inc.	2004	10
K062271	M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150…	Philips Medical Systems	2006	9
K081983	M3290A Intellivue Information Center Software, Release 1.00	Philips Medical Systems	2008	8
K102495	M3290B Intellivue Information Center Software, Release a.0	Philips Medical Systems	2010	7
K100420	Philips Obtracevue Model SW Rev. G.00	Philips Medizin Systeme Boeblingen GmbH	2010	4

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?

Its one ancestor has a recall.
Of its descendants, K040357 (Philips Medical Systems, Inc., 2004) has gone furthest, with 260 descendants of its own.
6 other devices also cite its predicate K011093.

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?

For central monitoring of multiple adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031403 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031403: M3290A Intellivue Information Center Software Release E.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031403

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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