# Opti Medical Systems, Inc.

- Location (FDA's records): Roswell, GA
- FDA decisions: 3 (2011–2021): 3 510(k) clearances
- Product codes: CHL (3)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Avl Scientific Corp.: 1 (https://510kreport.com/company/avl-scientific)
- Instrumentation Laboratory CO: 1 (https://510kreport.com/company/instrumentation-laboratory)
- Radiometer Medical Aps: 1 (https://510kreport.com/company/radiometer-medical)

## Its most-cited devices
- K131126: Opti Cca-TS2 (2013), cited by 1

## Recent decisions
- K200986: OPTI® B-Lac Cassette (Aug 2, 2021)
- K131126: Opti Cca-TS2 (Aug 22, 2013)
- K093280: Opti Cca-TS, B-Lac Cassette Model BP7561 (Jan 7, 2011)

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