510(k) · Cleared
ClearedHP Viridia Component Monitoring System, Model Rev. K
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 Jan 29, 1999 as substantially equivalent to K941811 (Hewlett-Packard Co., 1994) and 2 other predicates after a 16-day review. Its family tree reaches back 3 generations to 1994. 509 later devices descend from it.
- Decided
- Jan 29, 1999
- Review
- 16 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K941811 (1994). 8 ancestors in all, the oldest K922974 (1992). 509 later devices descend from it, 8 citing it directly.
- Root · 3 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 2 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 1 generation backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- This deviceK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- Descendant · cites it directly · 462 of its ownK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- Descendant · cites it directly · 451 of its ownK992273 HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor…Hewlett-Packard GmbH · 2000
- Descendant · cites it directly · 431 of its ownK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- Descendant · cites it directly · 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
Showing 5 of 509 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 509 · See all- K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH · 1999 · cites it directly462descendants
- 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
- K021300Modification of Philips Component Compact Monitor, Release a.03, Model M1275BPhilips Medical Systems · 2002 · cites it directly421descendants
- K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release…Philips Medical Systems · 2002 · 2 generations on416descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −2 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −1 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| 0 (this device) | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| +1 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| +1 | K992273 | HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor… | Hewlett-Packard GmbH | 2000 | — |
| +1 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 7 | 0 |
| 2003 | 5 | 0 |
| 2004 | 12 | 0 |
| 2005 | 13 | 0 |
| 2006 | 18 | 0 |
| 2007 | 9 | 0 |
| 2008 | 18 | 0 |
| 2009 | 20 | 0 |
| 2010 | 28 | 0 |
| 2011 | 30 | 0 |
| 2012 | 22 | 0 |
| 2013 | 20 | 0 |
| 2014 | 22 | 0 |
| 2015 | 19 | 0 |
| 2016 | 21 | 0 |
| 2017 | 22 | 0 |
| 2018 | 27 | 0 |
| 2019 | 18 | 0 |
| 2020 | 18 | 0 |
| 2021 | 21 | 0 |
| 2022 | 28 | 0 |
| 2023 | 27 | 0 |
| 2024 | 27 | 0 |
| 2025 | 29 | 0 |
| 2026 | 22 | 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? (3)
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 |
|---|---|---|---|
| * | K941811 | HP M1175A, M1176A, Component Monitoring SystemSummary page 1…e, Non-invasive 80.2910 Clinical Electronic Thermometer 3. The new combination device is substantially equivalent to previously cleared HP devices marketed pursuant to K941811, K973437 and K981376 Page 33 The modification is a software based change that combines software in the HP Clinic… | 1994 |
| * | K973437 | Hewlett-Packard Models M1001B Ecg M1002B Ecg/Respiration Plug-in ModulesSummary page 1…vasive 80.2910 Clinical Electronic Thermometer 3. The new combination device is substantially equivalent to previously cleared HP devices marketed pursuant to K941811, K973437 and K981376 Page 33 The modification is a software based change that combines software in the HP Clinical Monito… | 1997 |
| * | K981376 | Hewlett-Packard M1205A Viridia 24 CTSummary page 1…910 Clinical Electronic Thermometer 3. The new combination device is substantially equivalent to previously cleared HP devices marketed pursuant to K941811, K973437 and K981376 Page 33 The modification is a software based change that combines software in the HP Clinical Monitoring System… | 1999 |
What descends from it? (509)
See all 5098 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | 1999 | 462 |
| K992273 | HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor… | 2000 | 451 |
| K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276B | 2001 | 431 |
| K021300 | Modification of Philips Component Compact Monitor, Release a.03, Model M1275B | 2002 | 421 |
| K992674 | HP Viridia CMS Patient Monitor with Eeg Parameter, Model M1027A | 1999 | 409 |
| K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | 2002 | 407 |
| K014159 | Phillips M1175A/76A/77A Component Monitoring System; Phillips V24/V26 Patient Monitor | 2002 | 253 |
| K992636 | HP Carevue 9000 Clinical Information System, Model M2331A | 1999 | 78 |
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 8 ancestors has a recall.
- Of its descendants, K990972 (Hewlett-Packard GmbH, 1999) has gone furthest, with 462 descendants of its own.
- 6 other devices also cite its predicate K941811.
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 Viridia Component Monitoring System is intended for use in 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/K990125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990125: HP Viridia Component Monitoring System, Model Rev. K.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990125
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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