# First Sense Medical, LLC

- Location (FDA's records): Pontiac, MI
- FDA decisions: 2 (2016–2017): 2 510(k) clearances
- Product codes: LHQ (2)
- 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
- Infrared Sciences Corp.: 2 (https://510kreport.com/company/infrared-sciences)

## Recent decisions
- K162767: Sentinel BreastScan II System (Jan 9, 2017)
- K160573: FirstSense Breast Exam (Jun 1, 2016)

Source page: https://510kreport.com/company/first-sense-medical
