# BunkerHill Health

- Location (FDA's records): San Francisco, CA
- FDA decisions: 8 (2024–2026): 8 510(k) clearances
- Product codes: JAK (5), QIH (1), KGI (1), QYE (1)
- 510(k) review time since 2016: median 202 days, against 153 for FDA's reviews in the same codes and years (3 of 8 faster)
- Predicates its devices cite: 9 (3 its own); citations of its devices by later devices: 3 (3 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
- Bunkerhill, Inc.: 3 (https://510kreport.com/company/bunkerhill)
- Aidoc Medical, Ltd.: 1 (https://510kreport.com/company/aidoc-medical)
- HeartLung Corporation: 1 (https://510kreport.com/company/heartlung)
- Anumana, Inc.: 1 (https://510kreport.com/company/anumana)

## Its most-cited devices
- K243229: Bunkerhill AVC (2025), cited by 3

## Recent decisions
- K260166: Bunkerhill Contrast CAC (Mar 6, 2026)
- K260167: Bunkerhill Contrast AVC (Mar 6, 2026)
- K250662: Bunkerhill MAC (Oct 3, 2025)
- K250649: Bunkerhill ECG-EF (Sep 19, 2025)
- K243779: Bunkerhill Abdominal Aortic Quantification (AAQ) (Jul 1, 2025)
- K242295: BunkerHill BMD (Apr 8, 2025)
- K243229: Bunkerhill AVC (Jan 27, 2025)
- K240369: CAC (gated) Algorithm (Sep 27, 2024)

Source page: https://510kreport.com/company/bunkerhill-health
