510(k) · Cleared
ClearedHP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia Multi-Measurement Server and Compact Portable T
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hewlett-Packard GmbH · DSI Detector And Alarm, Arrhythmia
Cleared on Apr 19, 1999 as substantially equivalent to K971910 (Hewlett-Packard GmbH, 1998) and 4 other predicates after a 27-day review. Its family tree reaches back 4 generations to 1994. 462 later devices descend from it.
- Decided
- Apr 19, 1999
- Review
- 27 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K941811 (1994). 13 ancestors in all, the oldest K903523 (1990). 462 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 3 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 2 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 1 generation backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- This deviceK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- Descendant · cites it directly · 431 of its ownK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- Descendant · 2 generations on · 421 of its ownK021300 Modification of Philips Component Compact Monitor, Release a.03…Philips Medical Systems · 2002
- Descendant · 2 generations on · 416 of its ownK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- Descendant · 2 generations on · 407 of its ownK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 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 462 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 462 · 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −3 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −2 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −1 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| 0 (this device) | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| +1 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| +2 | K021300 | Modification of Philips Component Compact Monitor, Release a.03, Model M1275B | Philips Medical Systems | 2002 | — |
| +2 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| +2 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| +3 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 12 | 0 |
| 2005 | 13 | 0 |
| 2006 | 17 | 0 |
| 2007 | 7 | 0 |
| 2008 | 16 | 0 |
| 2009 | 20 | 0 |
| 2010 | 25 | 0 |
| 2011 | 26 | 0 |
| 2012 | 20 | 0 |
| 2013 | 18 | 0 |
| 2014 | 17 | 0 |
| 2015 | 16 | 0 |
| 2016 | 20 | 0 |
| 2017 | 19 | 0 |
| 2018 | 25 | 0 |
| 2019 | 18 | 0 |
| 2020 | 14 | 0 |
| 2021 | 19 | 0 |
| 2022 | 28 | 0 |
| 2023 | 27 | 0 |
| 2024 | 26 | 0 |
| 2025 | 29 | 0 |
| 2026 | 20 | 0 |
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 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K971910 | Multi-Parameter Module (M3000A)/Display Unit (M3046A)Summary page 1…Transducer and Electrode, Patient (including connector) 3. The new combination device is substantially equivalent to previously cleared HP devices marketed pursuant to K971910, K981576 and K990125, K903523, and K923343. 4. The modification is a software based change that involves only the Sp0, algorithm… | 1998 |
| * | K981576 | Multi-Parameter Module, Model M3000A & Display Unit, Model M3046ASummary page 1…er and Electrode, Patient (including connector) 3. The new combination device is substantially equivalent to previously cleared HP devices marketed pursuant to K971910, K981576 and K990125, K903523, and K923343. 4. The modification is a software based change that involves only the Sp0, algorithm of the m… | 1998 |
| * | K990125 | HP Viridia Component Monitoring System, Model Rev. KSummary page 1…rode, Patient (including connector) 3. The new combination device is substantially equivalent to previously cleared HP devices marketed pursuant to K971910, K981576 and K990125, K903523, and K923343. 4. The modification is a software based change that involves only the Sp0, algorithm of the measurement c… | 1999 |
| * | K903523 | HP Model M1020A, Arterial Oxygen Sat/Pleth ModuleSummary page 1…ient (including connector) 3. The new combination device is substantially equivalent to previously cleared HP devices marketed pursuant to K971910, K981576 and K990125, K903523, and K923343. 4. The modification is a software based change that involves only the Sp0, algorithm of the measurement computer p… | 1990 |
| * | K923343 | Hewlett-Packard Model M1020A Pulse OximeterSummary page 1…ng connector) 3. The new combination device is substantially equivalent to previously cleared HP devices marketed pursuant to K971910, K981576 and K990125, K903523, and K923343. 4. The modification is a software based change that involves only the Sp0, algorithm of the measurement computer processing uni… | 1993 |
What descends from it? (462)
See all 4626 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276B | 2001 | 431 |
| K030973 | Picosat II SPO2 Pulse Oximetry Module | 2003 | 198 |
| K032979 | Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193T | 2004 | 88 |
| K042306 | Philips SP02 Disposable Sensor, Model M1131A | 2004 | 76 |
| K052377 | Philips Disposable SPO2 Sensors MII32A and M1133A. | 2005 | 42 |
| K052707 | M3046B Compact Portable Patient Monitors | 2005 | 21 |
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 5 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K013199 (Philips Medical Systems, Inc., 2001) has gone furthest, with 431 descendants of its own.
- 11 other devices also cite its predicate K971910.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSI
243in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSI
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSI
712in 2025
MAUDE reports naming product code DSI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 151 | 4 | 64 |
| 2008 | 5 | 70 | 8 | 156 |
| 2009 | 6 | 73 | 3 | 279 |
| 2010 | 6 | 111 | 5 | 823 |
| 2011 | 6 | 114 | 3 | 793 |
| 2012 | 3 | 113 | 1 | 766 |
| 2013 | 1 | — | 0 | 795 |
| 2014 | 4 | 200 | 0 | 1,000 |
| 2015 | 9 | 127 | 0 | 1,645 |
| 2016 | 6 | 224 | 0 | 4,352 |
| 2017 | 0 | — | 0 | 3,594 |
| 2018 | 2 | — | 1 | 3,648 |
| 2019 | 3 | 243 | 4 | 3,485 |
| 2020 | 2 | — | 2 | 3,084 |
| 2021 | 0 | — | 0 | 3,092 |
| 2022 | 0 | — | 1 | 1,638 |
| 2023 | 2 | — | 2 | 1,616 |
| 2024 | 1 | — | 0 | 1,320 |
| 2025 | 1 | — | 18 | 712 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Hewlett-Packard family of patient monitor products is intended for monitoring, recording, and alarming of multiple physiological parameters. The devices are indicated for use in health care facilities by health care professionals whenever there is a need for monitoring the physiological parameters of adult, neonatal, and pediatric patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990972 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990972: HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia Multi-Measurement Server and Compact Portable T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990972
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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