Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Brightheart — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
99 daysmedian FDA review time
159 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252294 | Fetal EchoScan (v1.2) | Brightheart | 2025-12-08 | 138 | 0 |
| K251456 | BrightHeart View Classifier | Brightheart | 2025-06-05 | 24 | 0 |
| K243684 | BrightHeart View Classifier | Brightheart | 2025-05-07 | 159 | 0 |
| K251071 | Fetal EchoScan (v1.1) | Brightheart | 2025-05-02 | 25 | 0 |
| K242342 | Fetal EchoScan | Brightheart | 2024-11-14 | 99 | 0 |
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