# Critisense, Ltd.

- Location (FDA's records): Bonita Springs, FL
- FDA decisions: 2 (2006–2007): 2 510(k) clearances
- Product codes: DPW (2)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mallinckrodt Medical: 1 (https://510kreport.com/company/mallinckrodt-medical)
- Vital Medical, Ltd.: 1 (https://510kreport.com/company/vital-medical)

## Its most-cited devices
- K051145: Critiview (2006), cited by 1

## Recent decisions
- K062977: Critiview, Model CRV3 (Feb 28, 2007)
- K051145: Critiview (Jan 18, 2006)

Source page: https://510kreport.com/company/critisense