510(k) Report

FDA applicant

Criticare Systems, Inc.

Milwaukee, WI22 decisions1986–20104 recalls

FDA records 22 decisions for Criticare Systems, Inc. (Milwaukee, WI) from 1986 to 2010: 22 510(k) clearances. Most are in product codes DQA (Oximeter) and MWI (Monitor, Physiological, Patient (Without…). Its devices cite 9 predicates, 8 of them its own earlier devices. 4 recalls are linked to its devices.

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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Criticare Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2009: 12010: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2026

2013: 22026 (partial year): 1
2007high 2 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Criticare Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DQAOximeter4decisions
  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)3decisions
  • DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)3decisions
  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)2decisions
  • DSIDetector And Alarm, Arrhythmia2decisions
  • CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)1decision

Also: DRG (1), BTY (1), MLD (1), JOM (1), LOS (1), CBQ (1).

Whose devices does it build on?

Its devices cite 9 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 26 times; 8 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K0120598100/8500 Vital Signs MonitorCriticare Systems, Inc. · 20016cite it
  • K0010208100 Vital Signs MonitorCriticare Systems, Inc. · 20005cite it
  • K910770504US Pulse OximeterCriticare Systems, Inc. · 19912cite it
  • K942737Poet IQ with Five Agent CapabilityCriticare Systems, Inc. · 19952cite it
  • K910852507 Non-Invasive Vital Signs MonitorCriticare Systems, Inc. · 19912cite it
  • K022435507EL Vital Signs MonitorCriticare Systems, Inc. · 20022cite it

What has FDA decided for it lately?

  • 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
  • K0120598100/8500 Vital Signs MonitorCriticare Systems, Inc. · 2001
  • K0010208100 Vital Signs MonitorCriticare Systems, Inc. · 2000
  • K000276MPT 24 and Vital View 24Criticare Systems, Inc. · 2000

All 22 as Criticare Systems, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K030613nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT…May 6, 2026Class II
  • K042569Medrad Veris MR Monitor units The system is intended to monitor physiological parameters…Nov 21, 2013Class II
  • K042569DC power cable (p/n 3010556) supplied with the MEDRAD (R) Veris MR Vital Signs Monitor…Apr 15, 2013Class II
  • K042569Veris Invasive Blood Pressure Interface Cables-Part # 3010478. The product is an…Sep 29, 2006

Other applicant names beginning “Criticare”

FDA records each applicant name separately; these may or may not be the same firm.

Criticare Technologies Corp. 1