510(k) Report

510(k) · Cleared

Cleared

Multi-Parameter Module, Model M3000A & Display Unit, Model M3046A

K981576510(k) TraditionalCleared Jul 17, 199874-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 17, 1998 after a 74-day review. The FDA summary names no predicate by number. 472 later devices descend from it.

Decided
Jul 17, 1998
Review
74 days
Class
Class II
Product code
MHX
Recalls
None
Predicates
0

472 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2000: 2 descendants cleared2005: 13 descendants cleared2001: 3 descendants cleared1999: 2 descendants cleared2002: 7 descendants cleared2003: 5 descendants cleared2006: 17 descendants cleared2010: 25 descendants cleared2011: 26 descendants cleared2004: 12 descendants cleared2013: 18 descendants cleared2009: 20 descendants cleared2008: 16 descendants cleared2007: 8 descendants cleared2012: 20 descendants cleared2017: 19 descendants cleared2015: 16 descendants cleared2016: 20 descendants cleared2018: 25 descendants cleared2014: 17 descendants cleared2025: 29 descendants cleared2026: 20 descendants cleared2021: 19 descendants cleared2022: 28 descendants cleared2020: 14 descendants cleared2023: 27 descendants cleared2019: 18 descendants cleared2024: 26 descendants cleared1995200020052010201520202025
  1. This deviceK981576 Multi-Parameter Module, Model M3000A & Display Unit, Model M3046AHewlett-Packard GmbH · 1998
  2. Descendant · cites it directly · 462 of its ownK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  3. Descendant · cites it directly · 455 of its ownK991773 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  4. Descendant · cites it directly · 451 of its ownK993383 HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor…Hewlett-Packard GmbH · 2000 · Recalled
  5. Descendant · cites it directly · 451 of its ownK992273 HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor…Hewlett-Packard GmbH · 2000
  6. Descendant · cites it directly · 431 of its ownK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001

Showing 5 of 472 descendants. See all descendants

Descendants cleared per year

1999: 22000: 22001: 32002: 72003: 52004: 122005: 132006: 172007: 82008: 162009: 202010: 252011: 262012: 202013: 182014: 172015: 162016: 202017: 192018: 252019: 182020: 142021: 192022: 282023: 272024: 262025: 292026: 20
1999high 29 (2025) · low 2 (1999)2026

Most influential descendants

Showing 5 of 472 · See all
  • K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH · 1999 · cites it directly462descendants
  • K991773HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH · 1999 · cites it directly455descendants
  • K993383HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor Models M3000A…Hewlett-Packard GmbH · 2000 · cites it directly451descendants
  • K992273HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor…Hewlett-Packard GmbH · 2000 · cites it directly451descendants
  • K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276BPhilips Medical Systems, Inc. · 2001 · cites it directly431descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K981576Multi-Parameter Module, Model M3000A & Display Unit, Model M3046AHewlett-Packard GmbH1998—
+1K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
+1K991773HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
+1K993383HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor Models…Hewlett-Packard GmbH20002
+1K992273HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor…Hewlett-Packard GmbH2000—
+1K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199920
200020
200130
200270
200350
2004120
2005130
2006170
200780
2008160
2009200
2010250
2011260
2012200
2013180
2014170
2015160
2016200
2017190
2018250
2019180
2020140
2021190
2022280
2023270
2024260
2025290
2026200
FIG. 1 — Lineage of K981576, 1998–2026Source: 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), 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. #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 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?

The FDA summary names no predicate by number.

What descends from it? (472)

See all 472

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

NumberDeviceApplicantDecidedDescendants
K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999462
K991773HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999455
K993383HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor Models M3000A…Hewlett-Packard GmbH2000451
K992273HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor…Hewlett-Packard GmbH2000451
K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276BPhilips Medical Systems, Inc.2001431
K013427Modification to:Philips M3000A/M3046A Compact Portable Patient Monitor, Models Philips…Philips Medical Systems, Inc.2001407
K014159Phillips M1175A/76A/77A Component Monitoring System; Phillips V24/V26 Patient MonitorPhilips Medical Systems, Inc.2002253
K052707M3046B Compact Portable Patient MonitorsPhilips Medical Systems200521
K011824Agilent M2636B Telemon B Monitor (Telemon B)Agilent Technologies, Inc.20010

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, K990972 (Hewlett-Packard GmbH, 1999) has gone furthest, with 462 descendants of its own.

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

2007: 152008: 162009: 132010: 202011: 122012: 162013: 212014: 132015: 142016: 132017: 142018: 112019: 72020: 112021: 52022: 152023: 82024: 52025: 82026 (partial year): 14
2007high 21 (2013) · low 5 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHX

192in 2025

2007: 96 days median2008: 58 days median2009: 57 days median2010: 90 days median2011: 81 days median2012: 88 days median2013: 120 days median2014: 248 days median2015: 203 days median2016: 149 days median2017: 134 days median2018: 203 days median2019: 243 days median2020: 196 days median2021: 195 days median2022: 189 days median2023: 229 days median2024: 181 days median2025: 192 days median2026 (partial year): 205 days median
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

2007: 32008: 22009: 72010: 132011: 162012: 112013: 142014: 62015: 52016: 72017: 62018: 122019: 62022: 62023: 32024: 32025: 152026 (partial year): 21
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

2007: 1312008: 2322009: 3822010: 9552011: 9492012: 6762013: 1,9972014: 1,6092015: 1,2842016: 1,1052017: 1,1152018: 2,1572019: 1,4622020: 1,7142021: 2,4232022: 1,4702023: 2,2542024: 2,8142025: 3,761
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200715963131
200816582232
200913577382
2010209013955
2011128116949
2012168811676
201321120141,997
20141324861,609
20151420351,284
20161314971,105
20171413461,115
201811203122,157
2019724361,462
20201119601,714
2021519502,423
20221518961,470
2023822932,254
2024518132,814
20258192153,761
20261420521—

What is it indicated for?

The HP M3000A/M3046A Compact Portable Patient Monitor is indicated for use in health care facilities by health care professionals when the patient’s clinician deems it appropriate to use a device that:

a) Can measure and display multiple physiological parameters' and waves' of one patient, and can generate alarms and printouts based on those measurements.

b) Can be used on adult, pediatric, and neonatal patients as specified in the Technical Data Sheets.

1. List of supported measurements

(a) ECG

(b) Respiration

(¢) Invasive blood pressure

(d) Non-invasive blood pressure

(¢) SpO,and Pleth

(f) Temperature

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

More from Hewlett-Packard GmbH

16 FDA decisions under this applicant name. See the company

  • K993383HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor Models M3000A, M3046A, M3015A, Rel.BHewlett-Packard GmbH · 20002 recalls
  • K992273HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor M3000A/M3046A/M3016A,Rel BHewlett-Packard GmbH · 2000
  • K992595HP Viridia Component Monitoring System, Model Rev. K with Easi-ST Segment Measurement, HP Viridia CMS 24/26…Hewlett-Packard GmbH · 1999
  • K992674HP Viridia CMS Patient Monitor with Eeg Parameter, Model M1027AHewlett-Packard GmbH · 1999
  • K990476HP Viridia Component Monitoring System, HP Viridia CMS 24/26, Model Rev. K with Easi-Ecg OptionHewlett-Packard GmbH · 1999

Recent decisions in MHX

The MHX category page

  • K260676Radius VSM and AccessoriesMasimo Corporation · 2026
  • K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM…GE Healthcare Finland Oy · 2026
  • K260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy · 2026
  • K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc. · 2026
  • K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc. · 2026

https://510kreport.com/device/K981576 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981576: Multi-Parameter Module, Model M3000A & Display Unit, Model M3046A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981576

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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