# Biosensors International-USA

- Location (FDA's records): Newport Beach, CA
- FDA decisions: 3 (2003–2022): 2 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Biosensors International-USA (2); Biosensors International USA, Inc. (1)
- Product codes: DRS (1), NIQ (1), DQO (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 2 (0 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
- Sunscope Intl., Inc.: 1 (https://510kreport.com/company/sunscope-intl)
- Utah Medical Products, Inc.: 1 (https://510kreport.com/company/utah-medical-products)
- Gould, Inc.: 1 (https://510kreport.com/company/gould)

## Firms that cite its devices most
- Biometrix, Ltd.: 1 (https://510kreport.com/company/biometrix)
- B.Braun Melsungen AG: 1 (https://510kreport.com/company/b-braun-melsungen)

## Its most-cited devices
- K070710: Accutrans Disposable Pressure Monitoring System (2007), cited by 2

## Recent decisions
- P190020: BioFreedom Drug Coated Coronary Stent System (Apr 14, 2022)
- K070710: Accutrans Disposable Pressure Monitoring System (Apr 19, 2007)
- K022004: Cardiac Output Kit, Model CO-1 & Inline Sensor Cable, Model Ils-1 (Mar 12, 2003)

Source page: https://510kreport.com/company/biosensors-international-usa