510(k) · Cleared

Cleared

HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia Multi-Measurement Server and Compact Portable P

K991773510(k) SpecialCleared Jun 7, 199913-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 · DSI Detector And Alarm, Arrhythmia

Cleared on Jun 7, 1999 as substantially equivalent to K964122 (Hewlett-Packard Co., 1997) and 2 other predicates after a 13-day review. Its family tree reaches back 1 generation to 1997. 455 later devices descend from it.

Decided: Jun 7, 1999
Review: 13 days
Class: Class II
Product code: DSI
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K964122 (1997). 3 ancestors in all. 455 later devices descend from it, 8 citing it directly.

By dateBy generation

Root · 1 generation backK964122 HP Star ST and Arrhhythmia SoftwareHewlett-Packard Co. · 1997
This deviceK991773 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…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
Descendant · 3 generations on · 406 of its ownK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002

Showing 5 of 455 descendants. See all descendants

Descendants cleared per year

2001high 29 (2025) · low 2 (2001)2026

Most influential descendants

Showing 5 of 455 · See all

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
K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient…Philips Medical Systems · 2002 · 3 generations on406descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K964122	HP Star ST and Arrhhythmia Software	Hewlett-Packard Co.	1997	—
0 (this device)	K991773	HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…	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	—
+3	K023871	M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…	Philips Medical Systems	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	2	0
2002	6	0
2003	5	0
2004	10	0
2005	11	0
2006	16	0
2007	8	0
2008	16	0
2009	20	0
2010	23	0
2011	26	0
2012	20	0
2013	18	0
2014	17	0
2015	15	0
2016	19	0
2017	18	0
2018	25	0
2019	18	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 K991773, 1997–2026Source: 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 DSI? 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 DSI device

#1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 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? (3)

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
*	K964122	HP Star ST and Arrhhythmia Software Summary page 1 …ing connector) 3. The modified device is substantially equivalent to previously cleared HP devices that contain the same STAR software and that are marketed pursuant to K964122, K971910, and K981576. 4. The modification consists of the addition of software that involves only the arrhythmia and ST measure…	Hewlett-Packard Co.	1997	—
*	K971910	Multi-Parameter Module (M3000A)/Display Unit (M3046A) Summary page 1 …ctor) 3. The modified device is substantially equivalent to previously cleared HP devices that contain the same STAR software and that are marketed pursuant to K964122, K971910, and K981576. 4. The modification consists of the addition of software that involves only the arrhythmia and ST measurement algo…	Hewlett-Packard GmbH	1998	—
*	K981576	Multi-Parameter Module, Model M3000A & Display Unit, Model M3046A Summary page 1 …modified device is substantially equivalent to previously cleared HP devices that contain the same STAR software and that are marketed pursuant to K964122, K971910, and K981576. 4. The modification consists of the addition of software that involves only the arrhythmia and ST measurement algorithm of the…	Hewlett-Packard GmbH	1998	—

Also cleared against K964122: 7 other devices →

What descends from it? (455)

See all 455

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

Number	Device	Applicant	Decided	Descendants
K013199	Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276B	Philips Medical Systems, Inc.	2001	431
K014261	ST/AR ST and Arrhythmia Software, Model Release E.0	Philips Medical Systems, Inc.	2002	263
K021251	ST/AR ST and Arrhythmia Software, Release E.I.	Philips Medical Systems	2002	262
K052707	M3046B Compact Portable Patient Monitors	Philips Medical Systems	2005	21
K070260	Star ST and Arrhythmia Software, Release H.0	Philips Medical Systems	2007	7
K080461	Star ST and Arrhythmia Software, Release J.0	Philips Medical Systems	2008	6
K101521	ST/AR ST and Arrhythmia Software Model: Release K.O	Philips Medical Systems	2010	4
K011824	Agilent M2636B Telemon B Monitor (Telemon B)	Agilent Technologies, Inc.	2001	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?

None of the 3 ancestors has a recall.
Of its descendants, K013199 (Philips Medical Systems, Inc., 2001) has gone furthest, with 431 descendants of its own.
7 other devices also cite its predicate K964122.

How does its category compare?

All DSI devices

DSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DSI

1in 2025

2007high 9 (2015) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSI

243in 2019

2007high 243 (2019) · low 70 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DSI

18in 2025

2007high 18 (2025) · low 0 (2013)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DSI

712in 2025

2007high 4,352 (2016) · low 64 (2007)2025

MAUDE reports naming product code DSI, 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	7	151	4	64
2008	5	70	8	156
2009	6	73	3	279
2010	6	111	5	823
2011	6	114	3	793
2012	3	113	1	766
2013	1	—	0	795
2014	4	200	0	1,000
2015	9	127	0	1,645
2016	6	224	0	4,352
2017	0	—	0	3,594
2018	2	—	1	3,648
2019	3	243	4	3,485
2020	2	—	2	3,084
2021	0	—	0	3,092
2022	0	—	1	1,638
2023	2	—	2	1,616
2024	1	—	0	1,320
2025	1	—	18	712
2026	1	—	1	—

What is it indicated for?

The Hewlett-Packard family of patient monitor products is intended for monitoring, recording, and alarming of multiple physiological parameters. The devices are indicated for use in health care facilities by health care professionals whenever there is a need for monitoring the physiological parameters of adult, neonatal, and pediatric patients.

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/K991773 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991773: HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia Multi-Measurement Server and Compact Portable P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991773

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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