Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

BunkerHill Health · Predicate Candidate Screening

8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

204 daysmedian FDA review time
249 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260166Bunkerhill Contrast CACBunkerHill Health2026-03-06450
K260167Bunkerhill Contrast AVCBunkerHill Health2026-03-06450
K250662Bunkerhill MACBunkerHill Health2025-10-032120
K250649Bunkerhill ECG-EFBunkerHill Health2025-09-191990
K243779Bunkerhill Abdominal Aortic Quantification (AAQ)BunkerHill Health2025-07-012040
K242295BunkerHill BMDBunkerHill Health2025-04-082490
K243229Bunkerhill AVCBunkerHill Health2025-01-271110
K240369CAC (gated) AlgorithmBunkerHill Health2024-09-272330

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda