510(k) Report

510(k) · Cleared

Cleared

HP M1205A Omnicare Component Monitor System Model 24

K960934510(k) TraditionalCleared Jun 14, 199698-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. · MLD Monitor, St Segment With Alarm

Cleared on Jun 14, 1996 as substantially equivalent to K950821 (Hewlett-Packard Co., 1995) and 1 other predicate after a 98-day review. Its family tree reaches back 1 generation to 1994. 511 later devices descend from it.

Decided
Jun 14, 1996
Review
98 days
Class
Class II
Product code
MLD
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K941811 (1994). 2 ancestors in all. 511 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1999: 5 descendants cleared2004: 12 descendants cleared2007: 9 descendants cleared2012: 22 descendants cleared2005: 13 descendants cleared2006: 18 descendants cleared2009: 20 descendants cleared2011: 30 descendants cleared2010: 28 descendants cleared2013: 20 descendants cleared2008: 18 descendants cleared2015: 19 descendants cleared2002: 7 descendants cleared2000: 1 descendant cleared2001: 2 descendants cleared2003: 5 descendants cleared2016: 21 descendants cleared2017: 22 descendants cleared2018: 27 descendants cleared2014: 22 descendants cleared2021: 21 descendants cleared2022: 28 descendants cleared2020: 18 descendants cleared2023: 27 descendants cleared2019: 18 descendants cleared2025: 29 descendants cleared2026: 22 descendants cleared2024: 27 descendants clearedK941811 · HP M1175A, M1176A, Component Monitoring System · Hewlett-Packard Co. · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 37 descendants4 generations forward: 55 descendants5 generations forward: 85 descendants6 generations forward: 86 descendants7 generations forward: 96 descendants8 generations forward: 74 descendants9 generations forward: 38 descendants10 generations forward: 21 descendants11 generations forward: 12 descendants12 generations forward: 3 descendants13 generations forward: 1 descendant K941811 · HP M1175A, M1176A, Component Monitoring System · Hewlett-Packard Co. · 19940+5+10
  1. Root · 1 generation backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. This deviceK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. Descendant · cites it directly · 510 of its ownK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. Descendant · 2 generations on · 509 of its ownK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. Descendant · 3 generations on · 462 of its ownK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. Descendant · 3 generations on · 451 of its ownK992273 HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor…Hewlett-Packard GmbH · 2000
  7. Descendant · 3 generations on · 431 of its ownK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001

Showing 5 of 511 descendants. See all descendants

Descendants cleared per year

1999: 52000: 12001: 22002: 72003: 52004: 122005: 132006: 182007: 92008: 182009: 202010: 282011: 302012: 222013: 202014: 222015: 192016: 212017: 222018: 272019: 182020: 182021: 212022: 282023: 272024: 272025: 292026: 22
1999high 30 (2011) · low 1 (2000)2026

Most influential descendants

Showing 5 of 511 · See all
  • K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999 · cites it directly510descendants
  • K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999 · 2 generations on509descendants
  • K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH · 1999 · 3 generations on462descendants
  • K992273HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor…Hewlett-Packard GmbH · 2000 · 3 generations on451descendants
  • K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276BPhilips Medical Systems, Inc. · 2001 · 3 generations on431descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
0 (this device)K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
+1K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
+2K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
+3K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
+3K992273HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor…Hewlett-Packard GmbH2000—
+3K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199950
200010
200120
200270
200350
2004120
2005130
2006180
200790
2008180
2009200
2010280
2011300
2012220
2013200
2014220
2015190
2016210
2017220
2018270
2019180
2020180
2021210
2022280
2023270
2024270
2025290
2026220
FIG. 1 — Lineage of K960934, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 MLD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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.

TypeNumberDeviceApplicantDecidedRecalls
*K950821HP M1205A Omnicare Component Transport Monitoring System Model 24
Summary page 1
…24 Rev. C. Modification of the device was lim- ited to three of 29 functional blocks of software that comprise the OmniCare Model 24 Prod- uct (originally cleared under K950821). Changes to the OmniCare Model 24 device software were confined to the ECG/ Respiration, CO, and SpO,/PLETH functional blocks. M…
Hewlett-Packard Co.1995—
*K941811HP M1175A, M1176A, Component Monitoring System
Summary page 1
…ed to the ECG/ Respiration, CO, and SpO,/PLETH functional blocks. Modifica- tion was accomplished by reusing and leveraging software originally developed for CMS Rev. D (K941811). No new software was designed for this device. For that reason, the modifica- tion and this notification are nearly identical to…
Hewlett-Packard Co.1994—

Also cleared against K950821: 1 other device →

What descends from it? (511)

See all 511

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999510

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, K981376 (Hewlett-Packard Co., 1999) has gone furthest, with 510 descendants of its own.
  • 1 other device also cites its predicate K950821.

How does its category compare?

All MLD devices

MLD Monitor, St Segment With Alarm: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MLD

1in 2010

2008: 12010: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MLD

Too few MLD 510(k)s in any year since 2007 to give a median.

Recalls per year · MLD

No recall names MLD since 2007.

Adverse event reports per year · MLD

1in 2019

2007: 32008: 52009: 32010: 32011: 62012: 72014: 12015: 12017: 12018: 12019: 1
2007high 7 (2012) · low 0 (2013)2025

MAUDE reports naming product code MLD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—03
20081—05
20090—03
20101—03
20110—06
20120—07
20130—00
20140—01
20150—01
20160—00
20170—01
20180—01
20190—01
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The M1205A OmniCare Component Monitoring System is intended for monitoring, recording, and alarming of multiple physiological parameters for adult, neonatal and pediatric patients in the hospital environment.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K950821

1 other device cites the same predicate.

  • K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999

More from Hewlett-Packard Co.

230 FDA decisions under this applicant name. See the company

  • K992543Heartstream XLT Defibrillator/Monitor, AC Charger, DC Charger, Data Card, Single Bay Adapter, Defibrillator…Hewlett-Packard Co. · 2000
  • K993587HP M2376A Device Link SystemHewlett-Packard Co. · 2000
  • K993169Modification of: Physiological Signal Transmitter and Receiver, Model 3810AHewlett-Packard Co. · 1999
  • K992977Hewlett Packard Multifunction Pediatric Defib Function, Model M3503A & M3504AHewlett-Packard Co. · 1999
  • K993516HP M2600A Viridia Telemetry SystemHewlett-Packard Co. · 1999

Recent decisions in MLD

The MLD category page

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  • K022740Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU02 & L-CICU02A SoftwareDatex-Ohmeda · 20022 recalls
  • K012837Modification to: Datex-Ohmeda Cardiocap 5 (Rev B) and AccessoriesDatex-Ohmeda · 20012 recalls
  • K002105Siemens Infinity SC 6002XL Enhanced with ST Segment AnalysisSiemens Medical Solutions USA, Inc. · 2000

https://510kreport.com/device/K960934 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960934: HP M1205A Omnicare Component Monitor System Model 24.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960934

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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