510(k) Report

510(k) · Cleared

Cleared

8100 Vital Signs Monitor

K001020510(k) SpecialCleared Apr 28, 200029-day reviewClass II21 CFR 870.2300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Criticare Systems, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Cleared on Apr 28, 2000 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 271 devices in its family, counting itself, has a Class I recall. 270 later devices descend from it.

Decided
Apr 28, 2000
Review
29 days
Class
Class II
Product code
MWI
Recalls
None
Predicates
0

270 later devices descend from it, 5 citing it directly. 1 of the 271 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2005: 2 descendants cleared2006: 4 descendants cleared2003: 2 descendants cleared2004: 1 descendant cleared2007: 2 descendants cleared2008: 3 descendants cleared2011: 8 descendants cleared2010: 9 descendants cleared2009: 9 descendants cleared2016: 12 descendants cleared2018: 15 descendants cleared2012: 13 descendants cleared2013: 15 descendants cleared2015: 11 descendants cleared2014: 17 descendants cleared, 1 with a Class I recall12022: 24 descendants cleared2017: 12 descendants cleared2019: 16 descendants cleared2020: 15 descendants cleared2021: 11 descendants cleared2023: 16 descendants cleared2024: 20 descendants cleared2026: 15 descendants cleared2025: 18 descendants cleared200020052010201520202025
  1. This deviceK001020 8100 Vital Signs MonitorCriticare Systems, Inc. · 2000
  2. Descendant · cites it directly · 260 of its ownK032867 Star (Lunar Series) Monitoring SystemLarsen & Toubro Limited · 2003
  3. Descendant · cites it directly · 259 of its ownK051608 Star 50 Monitoring SystemLarsen & Toubro Limited · 2005
  4. Descendant · 2 generations on · 250 of its ownK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
  5. Descendant · 3 generations on · 197 of its ownK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
  6. Descendant · 4 generations on · 170 of its ownK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled

Showing 5 of 270 descendants. See all descendants

Descendants cleared per year

2003: 22004: 12005: 22006: 42007: 22008: 32009: 92010: 92011: 82012: 132013: 152014: 172015: 112016: 122017: 122018: 152019: 162020: 152021: 112022: 242023: 162024: 202025: 182026: 15
2003high 24 (2022) · low 1 (2004)2026

Class I recalls in this family

  • K123690 CAPNOSTREAM20P with Hifi C02 Monitoring8 generations on · 2014

Most influential descendants

Showing 5 of 270 · See all
  • K032867Star (Lunar Series) Monitoring SystemLarsen & Toubro Limited · 2003 · cites it directly260descendants
  • K051608Star 50 Monitoring SystemLarsen & Toubro Limited · 2005 · cites it directly259descendants
  • K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc. · 2006 · 2 generations on250descendants
  • K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007 · 3 generations on197descendants
  • K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · 4 generations on170descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K0010208100 Vital Signs MonitorCriticare Systems, Inc.2000—
+1K032867Star (Lunar Series) Monitoring SystemLarsen & Toubro Limited2003—
+1K051608Star 50 Monitoring SystemLarsen & Toubro Limited2005—
+2K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter…Oridion Capnography, Inc.20063
+3K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc.2007—
+4K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc.20099

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200410
200520
200640
200720
200830
200990
201090
201180
2012130
2013150
2014171
2015110
2016120
2017120
2018150
2019160
2020150
2021110
2022240
2023160
2024200
2025180
2026150
FIG. 1 — Lineage of K001020, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 MWI device

  1. #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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? (270)

See all 270

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K032867Star (Lunar Series) Monitoring SystemLarsen & Toubro Limited2003260
K051608Star 50 Monitoring SystemLarsen & Toubro Limited2005259
K032871Planet Monitoring SystemLarsen & Toubro Limited20038
K043370Planet 50 Monitoring SystemLarsen & Toubro Limited20052
K052544Pulse Oximeter Adapter CablesAmerican I.V. Products, Inc.20060

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.

  • K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd. · 2014 · 8 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K032867 (Larsen & Toubro Limited, 2003) has gone furthest, with 260 descendants of its own.

How does its category compare?

All MWI devices

MWI 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

2007: 92008: 92009: 62010: 172011: 112012: 132013: 202014: 162015: 192016: 122017: 132018: 112019: 142020: 82021: 92022: 52023: 82024: 102025: 42026 (partial year): 6
2007high 20 (2013) · low 4 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MWI

247in 2025

2007: 42 days median2008: 49 days median2009: 112 days median2010: 58 days median2011: 78 days median2012: 104 days median2013: 85 days median2014: 148 days median2015: 127 days median2016: 165 days median2017: 205 days median2018: 217 days median2019: 255 days median2020: 138 days median2021: 161 days median2022: 231 days median2023: 250 days median2024: 202 days median2025: 247 days median2026 (partial year): 239 days median
2007high 255 (2019) · low 42 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MWI

9so far in 2026, the most since 2007

2007: 12008: 12009: 22010: 22011: 32012: 52013: 32014: 62015: 12017: 22019: 42022: 22024: 52026 (partial year): 9
2007high 9 (2026) · low 0 (2016)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MWI

182in 2025

2007: 32008: 32009: 202010: 172011: 162012: 312013: 422014: 302015: 312016: 512017: 852018: 1582019: 1692020: 1102021: 1882022: 1682023: 1792024: 1202025: 182
2007high 188 (2021) · low 3 (2007)2025

MAUDE reports naming product code MWI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200794213
200894913
20096112220
20101758217
20111178316
201213104531
20132085342
201416148630
201519127131
201612165051
201713205285
2018112170158
2019142554169
202081380110
202191610188
202252312168
202382500179
2024102025120
202542470182
202662399—

More from Criticare Systems, Inc.

22 FDA decisions under this applicant name. See the company

  • K101602Vital Signs MonitorCriticare Systems, Inc. · 2010
  • K091050506CN Patient MonitorCriticare Systems, Inc. · 2009
  • K0425698600 Vital Signs MonitorCriticare Systems, Inc. · 20043 recalls
  • K030613Vital Signs Monitor W/Arrhythmia Detection and ST Analysis, Model 8100Criticare Systems, Inc. · 20031 recall
  • K022435507EL Vital Signs MonitorCriticare Systems, Inc. · 2002

Recent decisions in MWI

The MWI category page

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  • K253417Masimo Root Monitoring SystemMasimo Corporation · 2026
  • K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation · 2026
  • K253436c-med0 alphaCosinuss GmbH · 2026

https://510kreport.com/device/K001020 · printed Nov 3, 2026

Cite this page

510(k) Report. “K001020: 8100 Vital Signs Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K001020

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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