# Coagusense, Inc.

- Location (FDA's records): Fremont, CA
- FDA decisions: 3 (2010–2022): 3 510(k) clearances
- Product codes: GJS (3)
- Predicates its devices cite: 7 (2 its own); citations of its devices by later devices: 2 (2 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
- Farallon Medial, Inc.: 2 (https://510kreport.com/company/farallon-medial)
- Hemosense, Inc.: 2 (https://510kreport.com/company/hemosense)
- Roche Diagnostics Corp.: 1 (https://510kreport.com/company/roche-diagnostics)

## Its most-cited devices
- K093243: Coagusense Self-Test Prothrombin Time/Inr Monitoring System (2010), cited by 1
- K183255: Coag-Sense Prothrombin Time (PT) / INR Monitoring Device (2019), cited by 1

## Recent decisions
- K212779: Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing (Oct 5, 2022)
- K183255: Coag-Sense Prothrombin Time (PT) / INR Monitoring Device (Feb 21, 2019)
- K093243: Coagusense Self-Test Prothrombin Time/Inr Monitoring System (Apr 7, 2010)

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