510(k) Report

510(k) · Cleared

Cleared

HP Viridia Component Monitoring System, Model Rev. K with Easi-ST Segment Measurement, HP Viridia CMS 24/26, Rev K with

K992595510(k) SpecialCleared Dec 8, 1999127-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 Dec 8, 1999 as substantially equivalent to K990476 (Hewlett-Packard GmbH, 1999) after a 127-day review. Its family tree reaches back 2 generations to 1987. 436 later devices descend from it.

Decided
Dec 8, 1999
Review
127 days
Class
Class II
Product code
MHX
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K872781 (1987). 3 ancestors in all. 436 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor2006: 17 descendants cleared2003: 8 descendants cleared2001: 1 descendant cleared2002: 4 descendants cleared2010: 21 descendants cleared2011: 21 descendants cleared2005: 10 descendants cleared2008: 14 descendants cleared2004: 10 descendants cleared2007: 7 descendants cleared2009: 19 descendants cleared2012: 19 descendants cleared2014: 16 descendants cleared2013: 17 descendants cleared2015: 14 descendants cleared2016: 17 descendants cleared2017: 17 descendants cleared2018: 25 descendants cleared2025: 29 descendants cleared2026: 20 descendants cleared2021: 19 descendants cleared2022: 28 descendants cleared2020: 14 descendants cleared2023: 27 descendants cleared2019: 17 descendants cleared2024: 25 descendants clearedK872781 · Easi Lead System Cable Assembly · Totemite Medical Electronics · 1987K990476 · HP Viridia Component Monitoring System, HP Viridia CMS 24/26, Model Rev. K with Easi-Ecg Option · Hewlett-Packard GmbH · 19991990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 9 descendants3 generations forward: 59 descendants4 generations forward: 52 descendants5 generations forward: 67 descendants6 generations forward: 72 descendants7 generations forward: 70 descendants8 generations forward: 43 descendants9 generations forward: 22 descendants10 generations forward: 24 descendants11 generations forward: 13 descendants12 generations forward: 1 descendant K990476 · HP Viridia Component Monitoring System, HP Viridia CMS 24/26, Model Rev. K with Easi-Ecg Option · Hewlett-Packard GmbH · 1999K872781 · Easi Lead System Cable Assembly · Totemite Medical Electronics · 19870+5+10
  1. Root · 2 generations backK872781 Easi Lead System Cable AssemblyTotemite Medical Electronics · 1987
  2. 1 generation backK990476 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, Model…Hewlett-Packard GmbH · 1999
  3. This deviceK992595 HP Viridia Component Monitoring System, Model Rev. K with Easi-ST…Hewlett-Packard GmbH · 1999
  4. Descendant · cites it directly · 431 of its ownK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  5. Descendant · 2 generations on · 421 of its ownK021300 Modification of Philips Component Compact Monitor, Release a.03…Philips Medical Systems · 2002
  6. Descendant · 2 generations on · 416 of its ownK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  7. Descendant · 2 generations on · 407 of its ownK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  8. Descendant · 3 generations on · 406 of its ownK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002

Showing 5 of 436 descendants. See all descendants

Descendants cleared per year

2001: 12002: 42003: 82004: 102005: 102006: 172007: 72008: 142009: 192010: 212011: 212012: 192013: 172014: 162015: 142016: 172017: 172018: 252019: 172020: 142021: 192022: 282023: 272024: 252025: 292026: 20
2001high 29 (2025) · low 1 (2001)2026

Most influential descendants

Showing 5 of 436 · See all
  • K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276BPhilips Medical Systems, Inc. · 2001 · cites it directly431descendants
  • K021300Modification of Philips Component Compact Monitor, Release a.03, Model M1275BPhilips Medical Systems · 2002 · 2 generations on421descendants
  • K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release…Philips Medical Systems · 2002 · 2 generations on416descendants
  • K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002 · 2 generations on407descendants
  • K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient…Philips Medical Systems · 2002 · 3 generations on406descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K872781Easi Lead System Cable AssemblyTotemite Medical Electronics1987—
−1K990476HP Viridia Component Monitoring System, HP Viridia CMS 24/26, Model Rev. K…Hewlett-Packard GmbH1999—
0 (this device)K992595HP Viridia Component Monitoring System, Model Rev. K with Easi-ST Segment…Hewlett-Packard GmbH1999—
+1K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
+2K021300Modification of Philips Component Compact Monitor, Release a.03, Model M1275BPhilips Medical Systems2002—
+2K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
+2K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
+3K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200240
200380
2004100
2005100
2006170
200770
2008140
2009190
2010210
2011210
2012190
2013170
2014160
2015140
2016170
2017170
2018250
2019170
2020140
2021190
2022280
2023270
2024250
2025290
2026200
FIG. 1 — Lineage of K992595, 1987–2026Source: 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? (1)

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
*K990476HP Viridia Component Monitoring System, HP Viridia CMS 24/26, Model Rev. K with Easi-Ecg…
Summary page 1
…nitoring System M1175A/76A/77A and Viridia 24/26 M1205A devices with standard lead ST Segment measurement functionality enabled with EASI™ technology for ECG monitoring (K990476, June 22, 1999). The EASI™ ST Segment measurement will operate with the HP M1001A/B and M1002A/B ECG plug-in modules previously c…
Hewlett-Packard GmbH1999—

Also cleared against K990476: 2 other devices →

What descends from it? (436)

See all 436

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

NumberDeviceApplicantDecidedDescendants
K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276BPhilips Medical Systems, Inc.2001431
K030738Siemens Multiview Infinity Telemetry SystemSiemens Medical Solutions USA, Inc.20037
K06030712 RL AlgorithmGe Medical Systems Information Technologies20065
K023414Mida Algorithm Rev. BOrtivus AB20030

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?

  • The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 11.6 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K013199 (Philips Medical Systems, Inc., 2001) has gone furthest, with 431 descendants of its own.
  • 2 other devices also cite its predicate K990476.

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 Hewlett-Packard Viridia Component Monitoring System, (M1175A/76A/77A), and Viridia 24/26 (M1205A) Rev.K with with EASI™ ST segment Monitoring is indicated for:

Assessment of real time ST segment analysis in adult patients. Assessment is indicated for 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 K990476

2 other devices cite the same predicate.

  • K033513Easi Ecg AlgorithmPhilips Medical Systems · 2004
  • K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276BPhilips Medical Systems, Inc. · 2001

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
  • 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
  • K991773HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia Multi-Measurement Server and…Hewlett-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/K992595 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992595: HP Viridia Component Monitoring System, Model Rev. K with Easi-ST Segment Measurement, HP Viridia CMS 24/26, Rev K with.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992595

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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