510(k) Report

510(k) · Cleared

Cleared

HP M1175A, M1176A, Component Monitoring System

K941811510(k) TraditionalCleared May 17, 199435-day reviewClass II21 CFR 870.2340

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hewlett-Packard Co. · DPS Electrocardiograph

Cleared on May 17, 1994 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 556 devices in its family, counting itself, has a Class I recall. 555 later devices descend from it.

Decided
May 17, 1994
Review
35 days
Class
Class II
Product code
DPS
Recalls
None
Predicates
0

555 later devices descend from it, 7 citing it directly. 1 of the 556 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1999: 6 descendants cleared1996: 2 descendants cleared2001: 3 descendants cleared1998: 3 descendants cleared2010: 31 descendants cleared2003: 5 descendants cleared2002: 11 descendants cleared2006: 19 descendants cleared2011: 30 descendants cleared2013: 22 descendants cleared2000: 2 descendants cleared1997: 1 descendant cleared2005: 13 descendants cleared2004: 12 descendants cleared2008: 18 descendants cleared2007: 12 descendants cleared2009: 21 descendants cleared2012: 23 descendants cleared2014: 26 descendants cleared, 1 with a Class I recall12015: 22 descendants cleared2017: 26 descendants cleared2016: 22 descendants cleared2018: 28 descendants cleared2025: 29 descendants cleared2026: 22 descendants cleared2021: 23 descendants cleared2022: 29 descendants cleared2023: 27 descendants cleared2020: 19 descendants cleared2019: 20 descendants cleared2024: 28 descendants cleared1990200020102020
  1. This deviceK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. Descendant · cites it directly · 511 of its ownK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. Descendant · 2 generations on · 510 of its ownK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. Descendant · cites it directly · 509 of its ownK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. Descendant · 2 generations on · 462 of its ownK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. Descendant · 2 generations on · 451 of its ownK992273 HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor…Hewlett-Packard GmbH · 2000

Showing 5 of 555 descendants. See all descendants

Descendants cleared per year

1996: 21997: 11998: 31999: 62000: 22001: 32002: 112003: 52004: 122005: 132006: 192007: 122008: 182009: 212010: 312011: 302012: 232013: 222014: 262015: 222016: 222017: 262018: 282019: 202020: 192021: 232022: 292023: 272024: 282025: 292026: 22
1996high 31 (2010) · low 1 (1997)2026

Class I recalls in this family

  • K133576 Monitor B408 generations on · 2014

Most influential descendants

Showing 5 of 555 · 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 · 2 generations on510descendants
  • K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999 · cites it directly509descendants
  • K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH · 1999 · 2 generations on462descendants
  • K992273HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor…Hewlett-Packard GmbH · 2000 · 2 generations on451descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
199710
199830
199960
200020
200130
2002110
200350
2004120
2005130
2006190
2007120
2008180
2009210
2010310
2011300
2012230
2013220
2014261
2015220
2016220
2017260
2018280
2019200
2020190
2021230
2022290
2023270
2024280
2025290
2026220
FIG. 1 — Lineage of K941811, 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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 DPS device

  1. #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 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? (555)

See all 555

7 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
K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999509
K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276BPhilips Medical Systems, Inc.2001431
K955113Dinamap Select Multi-Parameter SystemJohnson & Johnson Medical, Inc.199644
K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037
K974510Envoy Patient MonitorMennen Medical, Inc.19981
K011824Agilent M2636B Telemon B Monitor (Telemon B)Agilent Technologies, Inc.20010

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 8 generations on · ◆ in the 2014 descendants bar of FIG. 11 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 DPS devices

DPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DPS

6in 2025

2007: 112008: 132009: 142010: 112011: 222012: 122013: 102014: 112015: 82016: 112017: 92018: 142019: 32020: 62021: 52022: 62023: 102024: 82025: 62026 (partial year): 6
2007high 22 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DPS

163in 2025

2007: 87 days median2008: 31 days median2009: 84 days median2010: 104 days median2011: 154 days median2012: 117 days median2013: 134 days median2014: 253 days median2015: 178 days median2016: 229 days median2017: 177 days median2018: 221 days median2019: 178 days median2020: 224 days median2021: 135 days median2022: 244 days median2023: 236 days median2024: 260 days median2025: 163 days median2026 (partial year): 258 days median
2007high 260 (2024) · low 31 (2008)2026

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

Recalls per year · DPS

3in 2025

2007: 22009: 12010: 22011: 12019: 92020: 22021: 12022: 12023: 32024: 4, 1 Class I2025: 32026 (partial year): 4
2007high 9 (2019) · low 0 (2008)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · DPS

55in 2025

2007: 92008: 172009: 142010: 212011: 1212012: 562013: 152014: 152015: 302016: 122017: 152018: 192019: 272020: 592021: 242022: 592023: 542024: 642025: 55
2007high 121 (2011) · low 9 (2007)2025

MAUDE reports naming product code DPS, 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
2007118729
20081331017
20091484114
201011104221
2011221541121
201212117056
201310134015
201411253015
20158178030
201611229012
20179177015
201814221019
20193178927
20206224259
20215135124
20226244159
202310236354
202482604 (1)64
20256163355
202662584—

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https://510kreport.com/device/K941811 · printed Nov 6, 2026

Cite this page

510(k) Report. “K941811: HP M1175A, M1176A, Component Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941811

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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