510(k) · Cleared
ClearedViridia Information Center Software for M3150A and M3153A, Viridia Telemetry System Transmitter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agilent Technologies, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Apr 10, 2000 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Apr 10, 2000
- Review
- 25 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 3 citing it directly.
- This deviceK000854 Viridia Information Center Software for M3150A and M3153A, Viridia…Agilent Technologies, Inc. · 2000
- Descendant · cites it directly · 8 of its ownK081983 M3290A Intellivue Information Center Software, Release 1.00Philips Medical Systems · 2008 · Recalled
- Descendant · cites it directly · 7 of its ownK102495 M3290B Intellivue Information Center Software, Release a.0Philips Medical Systems · 2010 · Recalled
- Descendant · 2 generations on · 4 of its ownK143057 M3290B Philips IntelliVue Information Center iXPhilips Medical Systems · 2014 · Recalled
- Descendant · 3 generations on · 3 of its ownK153702 M3290B Philips IntelliVue Information Center iXPhilips Medical Systems · 2016 · Recalled
- Descendant · 4 generations on · 2 of its ownK163584 M3290B Philips IntelliVue Information Center iXPhilips Medical Systems · 2017
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K081983M3290A Intellivue Information Center Software, Release 1.00Philips Medical Systems · 2008 · cites it directly8descendants
- K102495M3290B Intellivue Information Center Software, Release a.0Philips Medical Systems · 2010 · cites it directly7descendants
- K143057M3290B Philips IntelliVue Information Center iXPhilips Medical Systems · 2014 · 2 generations on4descendants
- K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems · 2016 · 3 generations on3descendants
- K163584M3290B Philips IntelliVue Information Center iXPhilips Medical Systems · 2017 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000854 | Viridia Information Center Software for M3150A and M3153A, Viridia Telemetry… | Agilent Technologies, Inc. | 2000 | — |
| +1 | K081983 | M3290A Intellivue Information Center Software, Release 1.00 | Philips Medical Systems | 2008 | 3 |
| +1 | K102495 | M3290B Intellivue Information Center Software, Release a.0 | Philips Medical Systems | 2010 | 7 |
| +2 | K143057 | M3290B Philips IntelliVue Information Center iX | Philips Medical Systems | 2014 | 1 |
| +3 | K153702 | M3290B Philips IntelliVue Information Center iX | Philips Medical Systems | 2016 | 12 |
| +4 | K163584 | M3290B Philips IntelliVue Information Center iX | Philips Medical Systems | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MHX? 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 MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
3 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?
- Of its descendants, K081983 (Philips Medical Systems, 2008) has gone furthest, with 8 descendants of its own.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, 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 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
https://510kreport.com/device/K000854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000854: Viridia Information Center Software for M3150A and M3153A, Viridia Telemetry System Transmitter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000854
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026