510(k) · Cleared

Cleared

Modification to:Philips M3000A/M3046A Compact Portable Patient Monitor, Models Philips M3000A/M3046A

K013427510(k) SpecialCleared Nov 29, 200144-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 Nov 29, 2001 as substantially equivalent to K971910 (Hewlett-Packard GmbH, 1998) and 1 other predicate after a 44-day review. Its family tree reaches back 1 generation to 1998. 407 later devices descend from it.

Decided: Nov 29, 2001
Review: 44 days
Class: Class II
Product code: MHX
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K971910 (1998). 2 ancestors in all. 407 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK971910 Multi-Parameter Module (M3000A)/Display Unit (M3046A)Hewlett-Packard GmbH · 1998
This deviceK013427 Modification to:Philips M3000A/M3046A Compact Portable Patient…Philips Medical Systems, Inc. · 2001
Descendant · cites it directly · 406 of its ownK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
Descendant · 2 generations on · 404 of its ownK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
Descendant · 3 generations on · 376 of its ownK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
Descendant · 3 generations on · 375 of its ownK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
Descendant · 4 generations on · 312 of its ownK040259 Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004

Showing 5 of 407 descendants. See all descendants

Descendants cleared per year

2002high 28 (2022) · low 1 (2002)2026

Most influential descendants

Showing 5 of 407 · See all

K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient…Philips Medical Systems · 2002 · cites it directly406descendants
K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185…Philips Medical Systems, Inc. · 2003 · 2 generations on404descendants
K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH · 2003 · 3 generations on376descendants
K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O.Philips Medizin Systeme Boblingen GmbH · 2003 · 3 generations on375descendants
K040259Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004 · 4 generations on312descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K971910	Multi-Parameter Module (M3000A)/Display Unit (M3046A)	Hewlett-Packard GmbH	1998	—
0 (this device)	K013427	Modification to:Philips M3000A/M3046A Compact Portable Patient Monitor, Models…	Philips Medical Systems, Inc.	2001	—
+1	K023871	M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…	Philips Medical Systems	2002	—
+2	K030038	Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…	Philips Medical Systems, Inc.	2003	—
+3	K031481	The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20	Philips Medizin Systeme Boblingen GmbH	2003	—
+3	K032858	The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…	Philips Medizin Systeme Boblingen GmbH	2003	—
+4	K040259	Masimo Set Intellivue Pulse Oximeter Module	Masimo Corp.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	4	0
2004	9	0
2005	9	0
2006	14	0
2007	6	0
2008	14	0
2009	15	0
2010	20	0
2011	19	0
2012	19	0
2013	17	0
2014	14	0
2015	14	0
2016	16	0
2017	17	0
2018	25	0
2019	17	0
2020	14	0
2021	18	0
2022	28	0
2023	26	0
2024	24	0
2025	28	0
2026	19	0

FIG. 1 — Lineage of K013427, 1998–2026Source: 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? (2)

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
*	K971910	Multi-Parameter Module (M3000A)/Display Unit (M3046A) Summary page 1 …logy Analyzer Panel 80 880.2910, II 80 FLL \| Clinical Electronic General Thermometer Hospital 3. The new device is substantially equivalent to the previously cleared M3 K971910 and K981576. 4. The modification provides an auscultatory validation reference, according to subclause 4.4.2.1 of AAMI SP-10 for…	Hewlett-Packard GmbH	1998	—
*	K981576	Multi-Parameter Module, Model M3000A & Display Unit, Model M3046A Summary page 1 …r Panel 80 880.2910, II 80 FLL \| Clinical Electronic General Thermometer Hospital 3. The new device is substantially equivalent to the previously cleared M3 K971910 and K981576. 4. The modification provides an auscultatory validation reference, according to subclause 4.4.2.1 of AAMI SP-10 for pediatric a…	Hewlett-Packard GmbH	1998	—

Also cleared against K971910: 11 other devices →

What descends from it? (407)

See all 407

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

Number	Device	Applicant	Decided	Descendants
K023871	M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient…	Philips Medical Systems	2002	406
K101600	Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2010	37

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?

None of the 2 ancestors has a recall.
Of its descendants, K023871 (Philips Medical Systems, 2002) has gone furthest, with 406 descendants of its own.
11 other devices also cite its predicate K971910.

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?

Intended for monitoring, recording, and alarming of multiple physiological

parameters of adults, pediatrics, and neonates in hospital and medical transport environments.

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/K013427 · printed Nov 5, 2026

Cite this page

510(k) Report. “K013427: Modification to:Philips M3000A/M3046A Compact Portable Patient Monitor, Models Philips M3000A/M3046A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013427

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026