Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QYE — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
174 daysmedian FDA review time
199 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250649 | Bunkerhill ECG-EF | BunkerHill Health | 2025-09-19 | 199 | 0 |
| K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | Anumana, Inc. | 2025-07-28 | 146 | 0 |
| K250119 | Tempus ECG-Low EF | Tempus AI, Inc. | 2025-07-15 | 180 | 0 |
| K233409 | Eko Low Ejection Fraction Tool (ELEFT) | Eko Health, Inc. | 2024-03-28 | 174 | 0 |
| K232699 | Low Ejection Fraction AI-ECG Algorithm | Anumana, Inc. | 2023-09-28 | 23 | 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