# Sunscope Intl., Inc.

- Location (FDA's records): Newport Beach, CA
- FDA decisions: 7 (1991–2000): 7 510(k) clearances
- Product codes: DRS (3), DQO (1), FOZ (1), DXE (1), KRB (1)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 3 (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
- Medex, Inc.: 2 (https://510kreport.com/company/medex)
- Utah Medical Products, Inc.: 1 (https://510kreport.com/company/utah-medical-products)
- Baxter Healthcare Corp: 1 (https://510kreport.com/company/baxter-healthcare)

## Firms that cite its devices most
- Biosensors International-USA: 1 (https://510kreport.com/company/biosensors-international-usa)
- Biosensors Intl. Pte., Ltd.: 1 (https://510kreport.com/company/biosensors-intl)
- Genesis Medical Interventional, Inc.: 1 (https://510kreport.com/company/genesis-medical-interventional)

## Its most-cited devices
- K981747: Biotrans Pressure Monitoring Kit Model Number BT Xxxxxx (1998), cited by 1
- K911710: Heparin Coated Thermodilution Cath & Accessories (1991), cited by 1
- K973477: Biosensors Embolectomy Catheter (1998), cited by 1

## Recent decisions
- K002786: Biosensors Central Venous Catheter Kits (Nov 17, 2000)
- K983372: Bioport Closed Blood Sampling System, Model BT Xxxxxx- BP (Feb 5, 1999)
- K973477: Biosensors Embolectomy Catheter (Sep 4, 1998)
- K981747: Biotrans Pressure Monitoring Kit Model Number BT Xxxxxx (Aug 20, 1998)
- K981745: Biotrans Reusable Sensor Base Model Number BT Xxxxxx (Jul 17, 1998)
- K911710: Heparin Coated Thermodilution Cath & Accessories (Oct 23, 1991)
- K912172: Safewedge (TM) Relief Valve Device (Sep 27, 1991)

Source page: https://510kreport.com/company/sunscope-intl