510(k) Report

510(k) · Cleared

Cleared

Portable Patient Monitor

K945134510(k) TraditionalCleared Oct 28, 19948-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. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Oct 28, 1994 after an 8-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 511 later devices descend from it.

Decided
Oct 28, 1994
Review
8 days
Class
Class II
Product code
MHX
Recalls
None
Predicates
0

511 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1999: 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 cleared1990200020102020
  1. This deviceK945134 Portable Patient MonitorHewlett-Packard Co. · 1994
  2. Descendant · cites it directly · 510 of its ownK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  3. Descendant · 2 generations on · 509 of its ownK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  4. Descendant · 3 generations on · 462 of its ownK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  5. Descendant · 3 generations on · 451 of its ownK992273 HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor…Hewlett-Packard GmbH · 2000
  6. 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
0 (this device)K945134Portable Patient MonitorHewlett-Packard Co.1994—
+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—

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 K945134, 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.

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
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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? (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?

  • Of its descendants, K981376 (Hewlett-Packard Co., 1999) has gone furthest, with 510 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—

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

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The MHX category page

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  • K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM…GE Healthcare Finland Oy · 2026
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https://510kreport.com/device/K945134 · printed Nov 5, 2026

Cite this page

510(k) Report. “K945134: Portable Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K945134

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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