Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Eko Health, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261694 | CORE 300 Digital Stethoscope | Eko Health, Inc. | 2026-07-23 | 62 | 0 |
| K251494 | Eko Foundation Analysis Software with Transformers (EFAST) | Eko Health, Inc. | 2025-08-12 | 89 | 0 |
| K233409 | Eko Low Ejection Fraction Tool (ELEFT) | Eko Health, Inc. | 2024-03-28 | 174 | 0 |
| K233609 | CORE 500 Digital Stethoscope | Eko Health, Inc. | 2024-03-28 | 136 | 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