510(k) · Cleared
ClearedViridia Information Center Software for M3154A Opt C22
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agilent Technologies, Inc. · MHD Pump, Infusion, Gallstone Dissolution
Cleared on Dec 6, 1999 as substantially equivalent to K964832 (Hewlett-Packard Co., 1997) and 1 other predicate after a 19-day review. Its family tree reaches back 2 generations to 1997. 428 later devices descend from it.
- Decided
- Dec 6, 1999
- Review
- 19 days
- Class
- Class II
- Product code
- MHD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K964832 (1997). 428 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK964832 Hewlett-Packard Centralvue SoftwareHewlett-Packard Co. · 1997
- 1 generation backK993171 HP Viridia Information System, Models M3150A/ M3151A/ M3153A/ M3154AHewlett-Packard Co. · 1999
- This deviceK993907 Viridia Information Center Software for M3154A Opt C22Agilent Technologies, Inc. · 1999
- Descendant · cites it directly · 426 of its ownK021422 Philips Information Center Software Revision D.02Philips 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
- Descendant · 3 generations on · 404 of its ownK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- Descendant · 3 generations on · 376 of its ownK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
Showing 5 of 428 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 428 · See all- 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
- K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH · 2003 · 3 generations on376descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K964832 | Hewlett-Packard Centralvue Software | Hewlett-Packard Co. | 1997 | — |
| −1 | K993171 | HP Viridia Information System, Models M3150A/ M3151A/ M3153A/ M3154A | Hewlett-Packard Co. | 1999 | — |
| 0 (this device) | K993907 | Viridia Information Center Software for M3154A Opt C22 | Agilent Technologies, Inc. | 1999 | — |
| +1 | K021422 | Philips Information Center Software Revision D.02 | 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 | — |
| +3 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| +3 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 9 | 0 |
| 2005 | 9 | 0 |
| 2006 | 15 | 0 |
| 2007 | 7 | 0 |
| 2008 | 15 | 0 |
| 2009 | 15 | 0 |
| 2010 | 21 | 0 |
| 2011 | 19 | 0 |
| 2012 | 20 | 0 |
| 2013 | 17 | 0 |
| 2014 | 16 | 0 |
| 2015 | 15 | 0 |
| 2016 | 16 | 0 |
| 2017 | 19 | 0 |
| 2018 | 26 | 0 |
| 2019 | 17 | 0 |
| 2020 | 16 | 0 |
| 2021 | 19 | 0 |
| 2022 | 28 | 0 |
| 2023 | 26 | 0 |
| 2024 | 25 | 0 |
| 2025 | 28 | 0 |
| 2026 | 21 | 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 MHD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K964832 | Hewlett-Packard Centralvue SoftwareSummary page 1…| 74 DSH lRecorder, Magnetic Tape, Medical I 3. The new device is substantially equivalent to the previouély cleared HP CentralVue Software device marketed pursuant to K964832, and K993171. 4. The modification is a software-based change that provides database server access via the hospital intra/interne… | 1997 |
| * | K993171 | HP Viridia Information System, Models M3150A/ M3151A/ M3153A/ M3154ASummary page 1…corder, Magnetic Tape, Medical I 3. The new device is substantially equivalent to the previouély cleared HP CentralVue Software device marketed pursuant to K964832, and K993171. 4. The modification is a software-based change that provides database server access via the hospital intra/internet system. 5.… | 1999 |
What descends from it? (428)
See all 4286 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021422 | Philips Information Center Software Revision D.02 | 2002 | 426 |
| K023698 | M3290A Intellivue Information Center Software Release E.O | 2002 | 11 |
| K040955 | M3290A Intellivue Information Center Software Release E.01 and Intellivue Clinical… | 2004 | 10 |
| K062271 | M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150… | 2006 | 9 |
| K081983 | M3290A Intellivue Information Center Software, Release 1.00 | 2008 | 8 |
| K102495 | M3290B Intellivue Information Center Software, Release a.0 | 2010 | 7 |
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 2 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K021422 (Philips Medical Systems, 2002) has gone furthest, with 426 descendants of its own.
- 5 other devices also cite its predicate K964832.
How does its category compare?
All MHD devicesMHD Pump, Infusion, Gallstone Dissolution: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MHD
FDA has decided no MHD device since 2007.
Median 510(k) review, days · MHD
Too few MHD 510(k)s in any year since 2007 to give a median.
Recalls per year · MHD
No recall names MHD since 2007.
Adverse event reports per year · MHD
No MAUDE report names MHD since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For central monitoring of multiple 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.
https://510kreport.com/device/K993907 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993907: Viridia Information Center Software for M3154A Opt C22.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993907
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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