510(k) · Cleared

Cleared

Hewlett-Packard Model 78730 Carevue 5000

K922210510(k) TraditionalCleared Apr 1, 1993324-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

Hewlett-Packard Co. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Apr 1, 1993 after a 324-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 80 later devices descend from it.

Decided: Apr 1, 1993
Review: 324 days
Class: Class II
Product code: MHX
Recalls: None
Predicates: 0

80 later devices descend from it, 2 citing it directly.

This deviceK922210 Hewlett-Packard Model 78730 Carevue 5000Hewlett-Packard Co. · 1993
Descendant · cites it directly · 78 of its ownK992636 HP Carevue 9000 Clinical Information System, Model M2331AHewlett-Packard Co. · 1999 · Recalled
Descendant · 2 generations on · 46 of its ownK100272 Intellivue Clinical Information PortfolioPhilips Medical Systems · 2010 · Recalled
Descendant · 2 generations on · 36 of its ownK111905 Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011
Descendant · 3 generations on · 35 of its ownK122223 New: Intellivue CL Respiration Pod New: Specialized Assessory…Philips Medizin Systeme Boeblingen GmbH · 2013
Descendant · 4 generations on · 24 of its ownK151736 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015

Showing 5 of 80 descendants. See all descendants

Descendants cleared per year

1997high 7 (2020) · low 0 (1998)2026

Most influential descendants

Showing 5 of 80 · See all

K992636HP Carevue 9000 Clinical Information System, Model M2331AHewlett-Packard Co. · 1999 · cites it directly78descendants
K100272Intellivue Clinical Information PortfolioPhilips Medical Systems · 2010 · 2 generations on46descendants
K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · 2 generations on36descendants
K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH · 2013 · 3 generations on35descendants
K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015 · 4 generations on24descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K922210	Hewlett-Packard Model 78730 Carevue 5000	Hewlett-Packard Co.	1993	—
+1	K992636	HP Carevue 9000 Clinical Information System, Model M2331A	Hewlett-Packard Co.	1999	8
+2	K100272	Intellivue Clinical Information Portfolio	Philips Medical Systems	2010	2
+2	K111905	Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2011	—
+3	K122223	New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp…	Philips Medizin Systeme Boeblingen GmbH	2013	—
+4	K151736	Philips IntelliVue GuardianSoftware	Philips Medizin Systeme Boblingen GmbH	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1999	1	0
2002	2	0
2006	1	0
2007	2	0
2008	2	0
2010	3	0
2011	5	0
2012	2	0
2013	4	0
2014	6	0
2015	4	0
2016	1	0
2017	4	0
2018	4	0
2019	2	0
2020	7	0
2021	4	0
2022	4	0
2023	4	0
2024	7	0
2025	6	0
2026	4	0

FIG. 1 — Lineage of K922210, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (80)

See all 80

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

Number	Device	Applicant	Decided	Descendants
K992636	HP Carevue 9000 Clinical Information System, Model M2331A	Hewlett-Packard Co.	1999	78
K965160	HP Orvue Intra-OP (M2510A)	Hewlett-Packard GmbH	1997	0

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?

Of its descendants, K992636 (Hewlett-Packard Co., 1999) has gone furthest, with 78 descendants of its own.

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	—

https://510kreport.com/device/K922210 · printed Nov 5, 2026

Cite this page

510(k) Report. “K922210: Hewlett-Packard Model 78730 Carevue 5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K922210

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026