510(k) Report

510(k) · Cleared

Cleared

HP M1205A Omnicare Component Transport Monitoring System Model 24

K950821510(k) TraditionalCleared Oct 3, 1995222-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. · DSI Detector And Alarm, Arrhythmia

Cleared on Oct 3, 1995 after a 222-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 512 later devices descend from it.

Decided
Oct 3, 1995
Review
222 days
Class
Class II
Product code
DSI
Recalls
None
Predicates
0

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

Descendants, by year cleared 1996: 1 descendant cleared1999: 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 cleared1995200020052010201520202025
  1. This deviceK950821 HP M1205A Omnicare Component Transport Monitoring System Model 24Hewlett-Packard Co. · 1995
  2. Descendant · cites it directly · 511 of its ownK960934 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

Showing 5 of 512 descendants. See all descendants

Descendants cleared per year

1996: 11999: 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
1996high 30 (2011) · low 0 (1997)2026

Most influential descendants

Showing 5 of 512 · See all
  • K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996 · cites it directly511descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950821HP M1205A Omnicare Component Transport Monitoring System Model 24Hewlett-Packard Co.1995—
+1K960934HP 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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
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 K950821, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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 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. #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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? (512)

See all 512

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

NumberDeviceApplicantDecidedDescendants
K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996511
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?

  • Of its descendants, K960934 (Hewlett-Packard Co., 1996) has gone furthest, with 511 descendants of its own.

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

2007: 72008: 52009: 62010: 62011: 62012: 32013: 12014: 42015: 92016: 62018: 22019: 32020: 22023: 22024: 12025: 12026 (partial year): 1
2007high 9 (2015) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSI

243in 2019

2007: 151 days median2008: 70 days median2009: 73 days median2010: 111 days median2011: 114 days median2012: 113 days median2014: 200 days median2015: 127 days median2016: 224 days median2019: 243 days median
2007high 243 (2019) · low 70 (2008)2026

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

Recalls per year · DSI

18in 2025

2007: 42008: 82009: 32010: 52011: 32012: 12018: 12019: 42020: 22022: 12023: 22025: 182026 (partial year): 1
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

2007: 642008: 1562009: 2792010: 8232011: 7932012: 7662013: 7952014: 1,0002015: 1,6452016: 4,3522017: 3,5942018: 3,6482019: 3,4852020: 3,0842021: 3,0922022: 1,6382023: 1,6162024: 1,3202025: 712
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20077151464
20085708156
20096733279
201061115823
201161143793
201231131766
20131—0795
2014420001,000
2015912701,645
2016622404,352
20170—03,594
20182—13,648
2019324343,485
20202—23,084
20210—03,092
20220—11,638
20232—21,616
20241—01,320
20251—18712
20261—1—

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  • K992977Hewlett Packard Multifunction Pediatric Defib Function, Model M3503A & M3504AHewlett-Packard Co. · 1999
  • K993516HP M2600A Viridia Telemetry SystemHewlett-Packard Co. · 1999

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The DSI category page

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  • K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc. · 2024
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https://510kreport.com/device/K950821 · printed Nov 5, 2026

Cite this page

510(k) Report. “K950821: HP M1205A Omnicare Component Transport Monitoring System Model 24.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K950821

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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