# Bioptimal International Pte., Ltd.

- Location (FDA's records): Singapore, SG
- FDA decisions: 2 (2025–2026): 2 510(k) clearances
- Product codes: LDF (1), DQO (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (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
- St Jude Medical: 1 (https://510kreport.com/company/st-jude-medical)
- Edwards Lifesciences, LLC: 1 (https://510kreport.com/company/edwards-lifesciences)

## Recent decisions
- K252702: Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N (May 28, 2026)
- K242863: Bioptimal Bipolar Pacing Catheter (Jun 15, 2025)

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