510(k) · Cleared
ClearedScholar Patient Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Criticare Systems, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Jun 20, 1995 after a 260-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 23 devices in its family, counting itself, has a Class I recall. 22 later devices descend from it.
- Decided
- Jun 20, 1995
- Review
- 260 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 0
22 later devices descend from it, 2 citing it directly. 1 of the 23 devices in this family, counting this one, has a Class I recall.
- This deviceK944860 Scholar Patient MonitorCriticare Systems, Inc. · 1995
- Descendant · cites it directly · 15 of its ownK012059 8100/8500 Vital Signs MonitorCriticare Systems, Inc. · 2001
- Descendant · 2 generations on · 7 of its ownK093261 MOVESThornhill Research, Inc. · 2010 · Recalled (Class I)
- Descendant · cites it directly · 6 of its ownK022435 507EL Vital Signs MonitorCriticare Systems, Inc. · 2002
- Descendant · 3 generations on · 4 of its ownK141460 Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2015
- Descendant · 2 generations on · 4 of its ownK051038 506 Patient MonitorCiriticare Systems, Inc. · 2005
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K093261 MOVES2 generations on · 2010
Most influential descendants
Showing 5 of 22 · See all- K0120598100/8500 Vital Signs MonitorCriticare Systems, Inc. · 2001 · cites it directly15descendants
- K093261MOVESThornhill Research, Inc. · 2010 · 2 generations on7descendants
- K022435507EL Vital Signs MonitorCriticare Systems, Inc. · 2002 · cites it directly6descendants
- K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2015 · 3 generations on4descendants
- K051038506 Patient MonitorCiriticare Systems, Inc. · 2005 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944860 | Scholar Patient Monitor | Criticare Systems, Inc. | 1995 | — |
| +1 | K012059 | 8100/8500 Vital Signs Monitor | Criticare Systems, Inc. | 2001 | — |
| +2 | K093261 | MOVES | Thornhill Research, Inc. | 2010 | Class I |
| +1 | K022435 | 507EL Vital Signs Monitor | Criticare Systems, Inc. | 2002 | — |
| +3 | K141460 | Finapres Nova Noninvasive Hemodynamic Monitor | Finapres Medical Systems B.V. | 2015 | — |
| +2 | K051038 | 506 Patient Monitor | Ciriticare Systems, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 1 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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.
1 device in this family has a Class I recall. 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? (22)
See all 222 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K093261MOVESThornhill Research, Inc. · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K012059 (Criticare Systems, Inc., 2001) has gone furthest, with 15 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/K944860 · printed Nov 5, 2026
Cite this page
510(k) Report. “K944860: Scholar Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K944860
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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