510(k) Report

510(k) · Cleared

Cleared

HP Viridia Information System, Models M3150A/ M3151A/ M3153A/ M3154A

K993171510(k) SpecialCleared Oct 21, 199930-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 21, 1999 as substantially equivalent to K964832 (Hewlett-Packard Co., 1997) after a 30-day review. Its family tree reaches back 1 generation to 1997. 429 later devices descend from it.

Decided
Oct 21, 1999
Review
30 days
Class
Class II
Product code
DSI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K964832 (1997). 429 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2002: 5 descendants cleared2006: 15 descendants cleared2008: 15 descendants cleared1999: 1 descendant cleared2010: 21 descendants cleared2004: 9 descendants cleared2013: 17 descendants cleared2014: 16 descendants cleared2007: 7 descendants cleared2005: 9 descendants cleared2009: 15 descendants cleared2003: 4 descendants cleared2011: 19 descendants cleared2012: 20 descendants cleared2016: 16 descendants cleared2015: 15 descendants cleared2017: 19 descendants cleared2018: 26 descendants cleared2021: 19 descendants cleared2020: 16 descendants cleared2023: 26 descendants cleared2022: 28 descendants cleared2019: 17 descendants cleared2025: 28 descendants cleared2024: 25 descendants cleared2026: 21 descendants clearedK964832 · Hewlett-Packard Centralvue Software · Hewlett-Packard Co. · 19971995200020052010201520202025
Descendants, by generation 1 generation forward: 6 descendants2 generations forward: 5 descendants3 generations forward: 34 descendants4 generations forward: 42 descendants5 generations forward: 65 descendants6 generations forward: 81 descendants7 generations forward: 72 descendants8 generations forward: 52 descendants9 generations forward: 29 descendants10 generations forward: 29 descendants11 generations forward: 13 descendants12 generations forward: 1 descendant K964832 · Hewlett-Packard Centralvue Software · Hewlett-Packard Co. · 19970+5+10
  1. Root · 1 generation backK964832 Hewlett-Packard Centralvue SoftwareHewlett-Packard Co. · 1997
  2. This deviceK993171 HP Viridia Information System, Models M3150A/ M3151A/ M3153A/ M3154AHewlett-Packard Co. · 1999
  3. Descendant · cites it directly · 428 of its ownK993907 Viridia Information Center Software for M3154A Opt C22Agilent Technologies, Inc. · 1999
  4. Descendant · cites it directly · 426 of its ownK021422 Philips Information Center Software Revision D.02Philips Medical Systems · 2002
  5. Descendant · 2 generations on · 407 of its ownK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  6. Descendant · 3 generations on · 406 of its ownK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  7. Descendant · 3 generations on · 404 of its ownK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003

Showing 5 of 429 descendants. See all descendants

Descendants cleared per year

1999: 12002: 52003: 42004: 92005: 92006: 152007: 72008: 152009: 152010: 212011: 192012: 202013: 172014: 162015: 152016: 162017: 192018: 262019: 172020: 162021: 192022: 282023: 262024: 252025: 282026: 21
1999high 28 (2022) · low 0 (2000)2026

Most influential descendants

Showing 5 of 429 · See all
  • K993907Viridia Information Center Software for M3154A Opt C22Agilent Technologies, Inc. · 1999 · cites it directly428descendants
  • K021422Philips Information Center Software Revision D.02Philips Medical Systems · 2002 · cites it directly426descendants
  • 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
  • K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185…Philips Medical Systems, Inc. · 2003 · 3 generations on404descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K964832Hewlett-Packard Centralvue SoftwareHewlett-Packard Co.1997—
0 (this device)K993171HP Viridia Information System, Models M3150A/ M3151A/ M3153A/ M3154AHewlett-Packard Co.1999—
+1K993907Viridia Information Center Software for M3154A Opt C22Agilent Technologies, Inc.1999—
+1K021422Philips Information Center Software Revision D.02Philips 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—
+3K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200250
200340
200490
200590
2006150
200770
2008150
2009150
2010210
2011190
2012200
2013170
2014160
2015150
2016160
2017190
2018260
2019170
2020160
2021190
2022280
2023260
2024250
2025280
2026210
FIG. 1 — Lineage of K993171, 1997–2026Source: 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), 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 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? (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
*K964832Hewlett-Packard Centralvue Software
Summary page 1
…None Physiological Monitor, Patient Monitor 3. The new device is substantially equivalent to the previously cleared HP CentralVue Software device marketed pursuant to K964832. 4. The modification is primarily a software based change that expands Remote Services Access capability to allow on-line troubl…
Hewlett-Packard Co.1997—

Also cleared against K964832: 5 other devices →

What descends from it? (429)

See all 429

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

NumberDeviceApplicantDecidedDescendants
K993907Viridia Information Center Software for M3154A Opt C22Agilent Technologies, Inc.1999428
K021422Philips Information Center Software Revision D.02Philips Medical Systems2002426
K040955M3290A Intellivue Information Center Software Release E.01 and Intellivue Clinical…Philips Medical Systems, Inc.200410
K062271M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150…Philips Medical Systems20069
K081983M3290A Intellivue Information Center Software, Release 1.00Philips Medical Systems20088
K102495M3290B Intellivue Information Center Software, Release a.0Philips Medical Systems20107

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?

  • Its one ancestor has no recall.
  • Of its descendants, K993907 (Agilent Technologies, Inc., 1999) has gone furthest, with 428 descendants of its own.
  • 5 other devices also cite its predicate K964832.

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—

What is it indicated for?

Indications: For central monitoring of mulXtiple adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

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 K964832

5 other devices cite the same predicate.

  • K102495M3290B Intellivue Information Center Software, Release a.0Philips Medical Systems · 20107 recalls
  • K081983M3290A Intellivue Information Center Software, Release 1.00Philips Medical Systems · 20083 recalls
  • K062271M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150, M3151, M3154, M3155…Philips Medical Systems · 20063 recalls
  • K021422Philips Information Center Software Revision D.02Philips Medical Systems · 2002
  • K993907Viridia Information Center Software for M3154A Opt C22Agilent Technologies, Inc. · 1999

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

Recent decisions in DSI

The DSI category page

  • K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc. · 2026
  • K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc. · 2025
  • K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc. · 2024
  • K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc. · 2023
  • K231276SmartCardia 7L PlatformSmartcardia SA · 2023

https://510kreport.com/device/K993171 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993171: HP Viridia Information System, Models M3150A/ M3151A/ M3153A/ M3154A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993171

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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