BunkerHill Health: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “BunkerHill Health” (first 2024, latest 2026), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 202 days. Since 2017 the median was 202 days, against 134 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2024 | 1 | 233 |
| 2025 | 5 | 204 |
| 2026 | 2 | 45 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name BunkerHill Health took a median 202 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 134 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 5 | 5 |
| KGI | Densitometer, Bone | 1 | 1 |
| QIH | Automated Radiological Image Processing Software | 1 | 1 |
| QYE | Reduced Ejection Fraction Machine Learning-Based Notification Software | 1 | 1 |
Review panels
- Radiology (7)
- Cardiovascular (1)
Most recent BunkerHill Health 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260167 | Bunkerhill Contrast AVC | JAK | 2026-03-06 | 45 |
| K260166 | Bunkerhill Contrast CAC | JAK | 2026-03-06 | 45 |
| K250662 | Bunkerhill MAC | JAK | 2025-10-03 | 212 |
| K250649 | Bunkerhill ECG-EF | QYE | 2025-09-19 | 199 |
| K243779 | Bunkerhill Abdominal Aortic Quantification (AAQ) | QIH | 2025-07-01 | 204 |
| K242295 | BunkerHill BMD | KGI | 2025-04-08 | 249 |
| K243229 | Bunkerhill AVC | JAK | 2025-01-27 | 111 |
| K240369 | CAC (gated) Algorithm | JAK | 2024-09-27 | 233 |
Recalls
openFDA lists no recalls under a recalling firm named BunkerHill Health.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Bunkerhill, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under BunkerHill Health?
FDA lists 8 510(k) clearances under the applicant name “BunkerHill Health” (first 2024, latest 2026), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by BunkerHill Health?
The median time from FDA receipt to decision across 510(k)s cleared under the name BunkerHill Health is 202 days. Since 2017: 202 days, versus 134 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under BunkerHill Health?
The most frequent FDA product codes under this applicant name are JAK (System, X-Ray, Tomography, Computed, 5); KGI (Densitometer, Bone, 1); QIH (Automated Radiological Image Processing Software, 1).
Next steps
- See all 8 BunkerHill Health clearances with predicates and recalls
- Run predicate analysis for product code JAK, BunkerHill Health's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.