Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Eko Devices, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
129 daysmedian FDA review time
205 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230111 | CORE 500 Digital Stethoscope | Eko Devices, Inc. | 2023-05-26 | 129 | 0 |
| K213794 | Eko Murmur Analysis Software (EMAS) | Eko Devices, Inc. | 2022-06-29 | 205 | 0 |
| K200776 | Eko CORE | Eko Devices, Inc. | 2020-04-06 | 12 | 0 |
| K192004 | Eko Analysis Software | Eko Devices, Inc. | 2020-01-15 | 173 | 0 |
| K170874 | Eko Model E5 System (EME5), Eko DUO | Eko Devices, Inc. | 2017-05-19 | 56 | 0 |
| K151319 | Eko Electronic Stethoscope System | Eko Devices, Inc. | 2015-08-28 | 102 | 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