510(k) · Cleared
ClearedModel M2350A and M2360A Wavevue Central Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hewlett-Packard Co. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Oct 1, 1992 after a 212-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Oct 1, 1992
- Review
- 212 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK921014 Model M2350A and M2360A Wavevue Central MonitorHewlett-Packard Co. · 1992
- Descendant · cites it directly · 2 of its ownK070588 Philips Suresigns VSV (Vital Signs Viewer)Philips Medical Systems · 2007 · Recalled
- Descendant · 2 generations on · 1 of its ownK131032 Philips Suresigns CentralPhilips Medical Systems · 2013
- Descendant · 3 generations on · 0 of its ownK160951 Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems · 2016 · Recalled
- Descendant · cites it directly · 0 of its ownK970358 Ensemble Central Station MonitorMennen Medical, Inc. · 1998
Most influential descendants
Showing 4 of 4 · See all- K070588Philips Suresigns VSV (Vital Signs Viewer)Philips Medical Systems · 2007 · cites it directly2descendants
- K131032Philips Suresigns CentralPhilips Medical Systems · 2013 · 2 generations on1descendant
- K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems · 2016 · 3 generations on0descendants
- K970358Ensemble Central Station MonitorMennen Medical, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K921014 | Model M2350A and M2360A Wavevue Central Monitor | Hewlett-Packard Co. | 1992 | — |
| +1 | K070588 | Philips Suresigns VSV (Vital Signs Viewer) | Philips Medical Systems | 2007 | 2 |
| +2 | K131032 | Philips Suresigns Central | Philips Medical Systems | 2013 | — |
| +3 | K160951 | Philips Efficia CMS200 Central Monitoring System | Philips Medical Systems | 2016 | 1 |
| +1 | K970358 | Ensemble Central Station Monitor | Mennen Medical, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 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? (4)
2 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, K070588 (Philips Medical Systems, 2007) has gone furthest, with 2 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/K921014 · printed Nov 6, 2026
Cite this page
510(k) Report. “K921014: Model M2350A and M2360A Wavevue Central Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K921014
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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