# Criticare Systems, Inc.

- Location (FDA's records): Milwaukee, WI
- FDA decisions: 22 (1986–2010): 22 510(k) clearances
- Product codes: DQA (4), MWI (3), DRT (3), MHX (2), DSI (2), CBS (1), DRG (1), BTY (1), MLD (1), JOM (1), LOS (1), CBQ (1)
- Predicates its devices cite: 9 (8 its own); citations of its devices by later devices: 26 (8 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ciriticare Systems, Inc.: 1 (https://510kreport.com/company/ciriticare-systems)

## Firms that cite its devices most
- Larsen & Toubro Limited: 4 (https://510kreport.com/company/larsen-toubro)
- Taidoc Technology Corporation: 2 (https://510kreport.com/company/taidoc-technology)
- Thornhill Research, Inc.: 2 (https://510kreport.com/company/thornhill-research)
- Invivo Research, Inc.: 1 (https://510kreport.com/company/invivo-research)
- Envitec-Wismar GmbH: 1 (https://510kreport.com/company/envitec-wismar)
- Biocare Corp.: 1 (https://510kreport.com/company/biocare)
- Envan, LLC: 1 (https://510kreport.com/company/envan)
- Keller Medical Specialties Products, Inc.: 1 (https://510kreport.com/company/keller-medical-specialties-products)

## Its most-cited devices
- K012059: 8100/8500 Vital Signs Monitor (2001), cited by 6
- K001020: 8100 Vital Signs Monitor (2000), cited by 5
- K910770: 504US Pulse Oximeter (1991), cited by 2
- K942737: Poet IQ with Five  Agent Capability (1995), cited by 2
- K910852: 507 Non-Invasive Vital Signs Monitor (1991), cited by 2
- K022435: 507EL Vital Signs Monitor (2002), cited by 2

## Recent decisions
- K101602: Vital Signs Monitor (Sep 1, 2010)
- K091050: 506CN Patient Monitor (May 27, 2009)
- K042569: 8600 Vital Signs Monitor (Sep 29, 2004)
- K030613: Vital Signs Monitor W/Arrhythmia Detection and ST Analysis, Model 8100 (Apr 17, 2003)
- K022435: 507EL Vital Signs Monitor (Aug 14, 2002)
- K012059: 8100/8500 Vital Signs Monitor (Aug 1, 2001)
- K001020: 8100 Vital Signs Monitor (Apr 28, 2000)
- K000276: MPT 24 and Vital View 24 (Mar 1, 2000)

Source page: https://510kreport.com/company/criticare-systems