510(k) · Cleared
Recalled · Class II · 2025HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor Models M3000A, M3046A, M3015A, Rel.B
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 Feb 3, 2000 as substantially equivalent to K981576 (Hewlett-Packard GmbH, 1998) and 1 other predicate after a 118-day review. Its family tree reaches back 1 generation to 1998. 451 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 3, 2000
- Review
- 118 days
- Class
- Class II
- Product code
- DSI
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 1 generation to K971910 (1998). 2 ancestors in all. 451 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK971910 Multi-Parameter Module (M3000A)/Display Unit (M3046A)Hewlett-Packard GmbH · 1998
- This deviceK993383 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 · 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 451 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 451 · 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 |
|---|---|---|---|---|---|
| −1 | K971910 | Multi-Parameter Module (M3000A)/Display Unit (M3046A) | Hewlett-Packard GmbH | 1998 | — |
| 0 (this device) | K993383 | HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor Models… | Hewlett-Packard GmbH | 2000 | — |
| +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 |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 10 | 0 |
| 2005 | 11 | 0 |
| 2006 | 16 | 0 |
| 2007 | 7 | 0 |
| 2008 | 16 | 0 |
| 2009 | 20 | 0 |
| 2010 | 23 | 0 |
| 2011 | 26 | 0 |
| 2012 | 20 | 0 |
| 2013 | 18 | 0 |
| 2014 | 17 | 0 |
| 2015 | 15 | 0 |
| 2016 | 19 | 0 |
| 2017 | 18 | 0 |
| 2018 | 25 | 0 |
| 2019 | 18 | 0 |
| 2020 | 14 | 0 |
| 2021 | 19 | 0 |
| 2022 | 28 | 0 |
| 2023 | 27 | 0 |
| 2024 | 25 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K964239 | FDA’s K964239 is Combination Oximeter/Carbon Dioxide Gas Analyzer Our OCR of the scanned summary read K964239, FDA’s number for Combination Oximeter/Carbon Dioxide Gas Analyzer (Spegas Industries, Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Nellcor Puritan Bennett NPB-75”. Kept off the family tree. Summary page 1…Electronic Thermometer The new combination device is substantially equivalent to previously cleared Nellcor Puritan Bennett™ NPB-75 and HP devices marketed pursuant to K964239, K981576 and K971910, respectively. 280 The modification is the addition of a firmware and software based change… | 1997 |
| * | K981576 | Multi-Parameter Module, Model M3000A & Display Unit, Model M3046ASummary page 1…ic Thermometer The new combination device is substantially equivalent to previously cleared Nellcor Puritan Bennett™ NPB-75 and HP devices marketed pursuant to K964239, K981576 and K971910, respectively. 280 The modification is the addition of a firmware and software based change that inv… | 1998 |
| * | K971910 | Multi-Parameter Module (M3000A)/Display Unit (M3046A)Summary page 1…er The new combination device is substantially equivalent to previously cleared Nellcor Puritan Bennett™ NPB-75 and HP devices marketed pursuant to K964239, K981576 and K971910, respectively. 280 The modification is the addition of a firmware and software based change that involves the ad… | 1998 |
What descends from it? (451)
See all 4513 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 7, 2025 | Class II | Z-1722-2025 | Unknown/Undetermined by firm | Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible. |
| Jun 8, 2020 | Class II | Z-2531-2020 | Device Design | Affected M3015A extensions are incompatible with the lntelliVue X3 Patient Monitor (Model No. 867030) and lntelliVue MMX multi-measurement server (Model No. 867036).If they are connected to a host monitor, communication with the X3 or MMX… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 M3/M4 (M3000A/M3046A) Patient Monitoring System, Rel.B is intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in the hospital and medical transport environments.
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/K993383 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993383: HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor Models M3000A, M3046A, M3015A, Rel.B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993383
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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