Company ยท FR
Brightheart
FDA 510(k) clearances and medical device recalls filed under this name, 2024 to 2025. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 8, 2025 | K252294 | Fetal EchoScan (v1.2) Brightheart, FR | POK |
| Jun 5, 2025 | K251456 | BrightHeart View Classifier Brightheart, FR | QIH |
| May 7, 2025 | K243684 | BrightHeart View Classifier Brightheart, FR | QIH |
| May 2, 2025 | K251071 | Fetal EchoScan (v1.1) Brightheart, FR | POK |
| Nov 14, 2024 | K242342 | Fetal EchoScan Brightheart, FR | POK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||