510(k) · Cleared
ClearedHewlett-Packard M1205A Viridia 24 CT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hewlett-Packard Co. · DSI Detector And Alarm, Arrhythmia
Cleared on Jan 4, 1999 as substantially equivalent to K950821 (Hewlett-Packard Co., 1995) and 4 other predicates after a 263-day review. Its family tree reaches back 2 generations to 1994. 510 later devices descend from it.
- Decided
- Jan 4, 1999
- Review
- 263 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K941811 (1994). 6 ancestors in all, the oldest K922974 (1992). 510 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 1 generation backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- This deviceK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- Descendant · cites it directly · 509 of its ownK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- Descendant · 2 generations on · 462 of its ownK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- Descendant · 2 generations on · 451 of its ownK992273 HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor…Hewlett-Packard GmbH · 2000
- Descendant · 2 generations on · 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
Showing 5 of 510 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 510 · See all- K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999 · cites it directly509descendants
- K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH · 1999 · 2 generations on462descendants
- K992273HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor…Hewlett-Packard GmbH · 2000 · 2 generations on451descendants
- K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276BPhilips Medical Systems, Inc. · 2001 · 2 generations on431descendants
- K021300Modification of Philips Component Compact Monitor, Release a.03, Model M1275BPhilips Medical Systems · 2002 · 2 generations on421descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −1 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| 0 (this device) | 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 | — |
| +2 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| +2 | K992273 | HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor… | Hewlett-Packard GmbH | 2000 | — |
| +2 | 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 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 4 | 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? (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 |
|---|---|---|---|
| * | K950821 | HP M1205A Omnicare Component Transport Monitoring System Model 24Summary page 1…r additional information. Or, a fax may be sent to (978) 685- 5624. Alternate contact: Chas Burr at (978) 659- 2529. Date 4/14/98 Regulatory Information References * K950821 and K960934, Hewlett-Packard M1205A Viridia 24 (formally OmniCare 24) » K922974 and K945134, Hewlett-Packard Model M1275A Compon… | 1995 |
| * | K960934 | HP M1205A Omnicare Component Monitor System Model 24Summary page 1…information. Or, a fax may be sent to (978) 685- 5624. Alternate contact: Chas Burr at (978) 659- 2529. Date 4/14/98 Regulatory Information References * K950821 and K960934, Hewlett-Packard M1205A Viridia 24 (formally OmniCare 24) » K922974 and K945134, Hewlett-Packard Model M1275A Component Transpor… | 1996 |
| * | K922974 | Portable Patient MonitorSummary page 1…tact: Chas Burr at (978) 659- 2529. Date 4/14/98 Regulatory Information References * K950821 and K960934, Hewlett-Packard M1205A Viridia 24 (formally OmniCare 24) » K922974 and K945134, Hewlett-Packard Model M1275A Component Transport System. » K961247, Datex AS/3 Compact Monitor 2.2 23 24 25 3.… | 1992 |
| * | K945134 | Portable Patient MonitorSummary page 1…urr at (978) 659- 2529. Date 4/14/98 Regulatory Information References * K950821 and K960934, Hewlett-Packard M1205A Viridia 24 (formally OmniCare 24) » K922974 and K945134, Hewlett-Packard Model M1275A Component Transport System. » K961247, Datex AS/3 Compact Monitor 2.2 23 24 25 3.0 4.0 4.1… | 1994 |
| * | K961247 | AS/3 Light MonitorSummary page 1…nces * K950821 and K960934, Hewlett-Packard M1205A Viridia 24 (formally OmniCare 24) » K922974 and K945134, Hewlett-Packard Model M1275A Component Transport System. » K961247, Datex AS/3 Compact Monitor 2.2 23 24 25 3.0 4.0 4.1 4.2 4.3 Device Name, Trade Name Proprietary: Hewlett-Packard M1205… | 1996 |
What descends from it? (510)
See all 5102 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 1 company; a new generation was cleared every 2.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K990125 (Hewlett-Packard GmbH, 1999) has gone furthest, with 509 descendants of its own.
- 1 other device also cites its predicate K950821.
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?
Condition: Viridia 24 CT is generally indicated when the clinician decides there is a need to measure and display multiple physiological parameters and waves, to generate alarms and recordings of adult, pediatric, or neonatal patients. Part of Body or Type of Tissue with Which the Device Interacts: Viridia 24 CT does not contact the body or tissue of the patient. Signals are obtained from accessory electrode, transducer, and sensor devices. Frequency of…
Read the full statement (140 words)
Condition: Viridia 24 CT is generally indicated when the clinician decides there is a need to measure and display multiple physiological parameters and waves, to generate alarms and recordings of adult, pediatric, or neonatal patients.
Part of Body or Type of Tissue with Which the Device Interacts: Viridia 24 CT does not contact the body or tissue of the patient. Signals are obtained from accessory electrode, transducer, and sensor devices.
Frequency of Use: Viridia 24 CT is indicated for use when prescribed by a clinician.
Physiological Purpose: Viridia 24 CT is indicated when the purpose is to gain information for treatment, to assess adequacy of treatment, or to rule out causes of symptoms. Viridia 24 CT is well suited for patient monitoring.
Patient Population: Adult, pediatric, and neonatal non-ambulatory patients.
Prescription Versus Over-the-Counter: Viridia 24 CT is a prescription device.
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/K981376 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981376: Hewlett-Packard M1205A Viridia 24 CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981376
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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