510(k) · Cleared
Cleared8100/8500 Vital Signs Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Criticare Systems, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Aug 1, 2001 as substantially equivalent to K944860 (Criticare Systems, Inc., 1995) and 1 other predicate after a 30-day review. Its family tree reaches back 1 generation to 1995. 1 of the 18 devices in its family, counting itself, has a Class I recall. 15 later devices descend from it.
- Decided
- Aug 1, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K942737 (1995). 2 ancestors in all. 15 later devices descend from it, 6 citing it directly. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK942737 Poet IQ with Five Agent CapabilityCriticare Systems, Inc. · 1995
- This deviceK012059 8100/8500 Vital Signs MonitorCriticare Systems, Inc. · 2001
- Descendant · cites it directly · 7 of its ownK093261 MOVESThornhill Research, Inc. · 2010 · Recalled (Class I)
- Descendant · 2 generations on · 4 of its ownK141460 Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2015
- Descendant · 3 generations on · 3 of its ownK160967 Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2017
- Descendant · cites it directly · 3 of its ownK081891 Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorFukuda Denshi USA, Inc. · 2008
- Descendant · 3 generations on · 2 of its ownK173916 Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2018
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K093261 MOVEScites it directly · 2010
Most influential descendants
Showing 5 of 15 · See all- K093261MOVESThornhill Research, Inc. · 2010 · cites it directly7descendants
- K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2015 · 2 generations on4descendants
- K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2017 · 3 generations on3descendants
- K081891Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorFukuda Denshi USA, Inc. · 2008 · cites it directly3descendants
- K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2018 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942737 | Poet IQ with Five Agent Capability | Criticare Systems, Inc. | 1995 | — |
| 0 (this device) | K012059 | 8100/8500 Vital Signs Monitor | Criticare Systems, Inc. | 2001 | — |
| +1 | K093261 | MOVES | Thornhill Research, Inc. | 2010 | Class I |
| +2 | K141460 | Finapres Nova Noninvasive Hemodynamic Monitor | Finapres Medical Systems B.V. | 2015 | — |
| +3 | K160967 | Finapres Nova Noninvasive Hemodynamic Monitor | Finapres Medical Systems B.V. | 2017 | — |
| +1 | K081891 | Fukuda Denshi Dynascope Model DS-7000/7000M Patient Monitor | Fukuda Denshi USA, Inc. | 2008 | — |
| +3 | K173916 | Finapres Nova Noninvasive Hemodynamic Monitor | Finapres Medical Systems B.V. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 1 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 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.
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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K944860 | Scholar Patient MonitorSummary page 1…: Vital Signs Monitor Classification Name: Monitor, Physiological, Patient (74 MWI) Substantial Equivalence is claimed to : CSI Model 2200 Scholar Vital Signs Monitor (K944860) and CSI POET IQ 5-Agent Monitor (K942737) Device Description: The 8100 / 8500 monitor measures and displays real time physiolo… | 1995 |
| * | K942737 | Poet IQ with Five Agent CapabilitySummary page 1…Monitor, Physiological, Patient (74 MWI) Substantial Equivalence is claimed to : CSI Model 2200 Scholar Vital Signs Monitor (K944860) and CSI POET IQ 5-Agent Monitor (K942737) Device Description: The 8100 / 8500 monitor measures and displays real time physiological data of the patient, including wavef… | 1995 |
What descends from it? (15)
See all 156 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 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarms and patient data analysis will be available to the care provider from the monitor.
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/K012059 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012059: 8100/8500 Vital Signs Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012059
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026