510(k) · Cleared

Cleared

HP Viridia Component Monitoring System, HP Viridia CMS 24/26, Model Rev. K with Easi-Ecg Option

K990476510(k) TraditionalCleared Jul 22, 1999156-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 GmbH · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Jul 22, 1999 as substantially equivalent to K872781 (Totemite Medical Electronics, 1987) and 1 other predicate after a 156-day review. Its family tree reaches back 1 generation to 1987. 437 later devices descend from it.

Decided: Jul 22, 1999
Review: 156 days
Class: Class II
Product code: MHX
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K872781 (1987). 2 ancestors in all. 437 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK872781 Easi Lead System Cable AssemblyTotemite Medical Electronics · 1987
This deviceK990476 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, Model…Hewlett-Packard GmbH · 1999
Descendant · cites it directly · 436 of its ownK992595 HP Viridia Component Monitoring System, Model Rev. K with Easi-ST…Hewlett-Packard GmbH · 1999
Descendant · cites it directly · 431 of its ownK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
Descendant · 2 generations on · 421 of its ownK021300 Modification of Philips Component Compact Monitor, Release a.03…Philips Medical Systems · 2002
Descendant · 2 generations on · 416 of its ownK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
Descendant · 2 generations on · 407 of its ownK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002

Showing 5 of 437 descendants. See all descendants

Descendants cleared per year

1999high 29 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 437 · See all

K992595HP Viridia Component Monitoring System, Model Rev. K with Easi-ST Segment Measurement…Hewlett-Packard GmbH · 1999 · cites it directly436descendants
K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276BPhilips Medical Systems, Inc. · 2001 · cites it directly431descendants
K021300Modification of Philips Component Compact Monitor, Release a.03, Model M1275BPhilips Medical Systems · 2002 · 2 generations on421descendants
K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release…Philips Medical Systems · 2002 · 2 generations on416descendants
K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002 · 2 generations on407descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K872781	Easi Lead System Cable Assembly	Totemite Medical Electronics	1987	—
0 (this device)	K990476	HP Viridia Component Monitoring System, HP Viridia CMS 24/26, Model Rev. K…	Hewlett-Packard GmbH	1999	—
+1	K992595	HP Viridia Component Monitoring System, Model Rev. K with Easi-ST Segment…	Hewlett-Packard GmbH	1999	—
+1	K013199	Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…	Philips Medical Systems, Inc.	2001	—
+2	K021300	Modification of Philips Component Compact Monitor, Release a.03, Model M1275B	Philips Medical Systems	2002	—
+2	K020531	Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…	Philips Medical Systems	2002	—
+2	K021778	Philips Component Compact Monitor, Release a.04, Model #M1275B	Philips Medical Systems	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2001	1	0
2002	4	0
2003	8	0
2004	10	0
2005	10	0
2006	17	0
2007	7	0
2008	14	0
2009	19	0
2010	21	0
2011	21	0
2012	19	0
2013	17	0
2014	16	0
2015	14	0
2016	17	0
2017	17	0
2018	25	0
2019	17	0
2020	14	0
2021	19	0
2022	28	0
2023	27	0
2024	25	0
2025	29	0
2026	20	0

FIG. 1 — Lineage of K990476, 1987–2026Source: 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
*	K872781	Easi Lead System Cable Assembly Summary page 1 …ctor and Alarm, Arrythmia 3. The new device with the EASI-ECG Option is substantially equivalent to the following predicate devices: the Totemite EASI Lead System Cable K872781B (12/29/87), and the Zymed T8010 Telemetry Central Station Monitor K951370 (10/6/95). The accessories and materials are optional…	Totemite Medical Electronics	1987	—
*	K951370	Zymed Telemetry System; Model T8010 Summary page 1 …bstantially equivalent to the following predicate devices: the Totemite EASI Lead System Cable K872781B (12/29/87), and the Zymed T8010 Telemetry Central Station Monitor K951370 (10/6/95). The accessories and materials are optional and are the same accessories originally cleared for use with HP M1175A/76A…	Zymed Medical Instrumentation	1995	—
†	K882609	Models M1175A & M1176A Component Monitoring System	Waltham Div. Hewlett Packard	1989	—
†	K973437	Hewlett-Packard Models M1001B Ecg M1002B Ecg/Respiration Plug-in Modules	Hewlett-Packard GmbH	1997	—

Also cleared against K872781: 1 other device →

What descends from it? (437)

See all 437

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

Number	Device	Applicant	Decided	Descendants
K992595	HP Viridia Component Monitoring System, Model Rev. K with Easi-ST Segment Measurement…	Hewlett-Packard GmbH	1999	436
K013199	Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276B	Philips Medical Systems, Inc.	2001	431
K033513	Easi Ecg Algorithm	Philips Medical Systems	2004	220

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, K992595 (Hewlett-Packard GmbH, 1999) has gone furthest, with 436 descendants of its own.
1 other device also cites its predicate K872781.

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?

The Hewlett-Packard Viridia Component Monitoring System, (M1175A/76A/77RA), and Viridia 24/26 (M1205A) Rev.K with EASI-ECG Option is indicated for:

Assessment of symptoms that may be related to rhythm disturbances of the heart: patients with palpitations, the evaluation of arrhythmia’s in adult and pediatric patients.

Assessment of risk in patients with or without symptoms of arrhythmia.

Assessment of efficacy of antiarrhythmic therapy.

Assessment of pacemaker function.

Assessment of symptomatic or asymptomatic patients to evaluate for ischemic heart disease.

Assessment is indicated for single-hospital environment.

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/K990476 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990476: HP Viridia Component Monitoring System, HP Viridia CMS 24/26, Model Rev. K with Easi-Ecg Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990476

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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