Brightheart: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Brightheart” (first 2024, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 99 days. Since 2017 the median was 99 days, against 140 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 | 99 |
| 2025 | 4 | 82 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Brightheart took a median 99 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| POK | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | 3 | 3 |
| QIH | Automated Radiological Image Processing Software | 2 | 2 |
Review panels
- Radiology (5)
Most recent Brightheart 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252294 | Fetal EchoScan (v1.2) | POK | 2025-12-08 | 138 |
| K251456 | BrightHeart View Classifier | QIH | 2025-06-05 | 24 |
| K243684 | BrightHeart View Classifier | QIH | 2025-05-07 | 159 |
| K251071 | Fetal EchoScan (v1.1) | POK | 2025-05-02 | 25 |
| K242342 | Fetal EchoScan | POK | 2024-11-14 | 99 |
Recalls
openFDA lists no recalls under a recalling firm named Brightheart.
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.
Device clinical trials
An industry sponsor named Brightheart is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06392555: Fetal Heart Ultrasound Suspicious Radiographic Finding Identification - Reader Study (Completed, started 2024-05-03)
Frequently asked questions
How many FDA 510(k) clearances are listed under Brightheart?
FDA lists 5 510(k) clearances under the applicant name “Brightheart” (first 2024, latest 2025), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Brightheart?
The median time from FDA receipt to decision across 510(k)s cleared under the name Brightheart is 99 days. Since 2017: 99 days, versus 140 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Brightheart?
The most frequent FDA product codes under this applicant name are POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer, 3); QIH (Automated Radiological Image Processing Software, 2).
Next steps
- See all 5 Brightheart clearances with predicates and recalls
- Run predicate analysis for product code POK, Brightheart'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.