Eko Devices, Inc.: FDA clearances and approvals
Eko Devices, Inc. has 6 FDA 510(k) clearances (first 2015, latest 2023), across 2 product codes in 1 review panel. Median 510(k) review time: 116 days. Since 2017 its median was 129 days, against 184 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 15 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 102 |
| 2016 | 0 | — |
| 2017 | 1 | 56 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 92 |
| 2021 | 0 | — |
| 2022 | 1 | 205 |
| 2023 | 1 | 129 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Eko Devices, Inc.'s cleared 510(k)s took a median 129 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 184 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQD | Stethoscope, Electronic | 5 | 5 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 1 | 1 |
Review panels
- Cardiovascular (6)
Most recent Eko Devices, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230111 | CORE 500 Digital Stethoscope | DQD | 2023-05-26 | 129 |
| K213794 | Eko Murmur Analysis Software (EMAS) | DQD | 2022-06-29 | 205 |
| K200776 | Eko CORE | DQD | 2020-04-06 | 12 |
| K192004 | Eko Analysis Software | MWI | 2020-01-15 | 173 |
| K170874 | Eko Model E5 System (EME5), Eko DUO | DQD | 2017-05-19 | 56 |
| K151319 | Eko Electronic Stethoscope System | DQD | 2015-08-28 | 102 |
Recalls
openFDA lists no recalls under a recalling firm named Eko Devices, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Eko Devices, Inc. is the industry lead sponsor of 15 device studies on ClinicalTrials.gov (7 active or recruiting). Most recent:
- NCT07270744: Data Collection Using Eko Devices in a Clinical Setting (Recruiting, started 2025-10-01)
- NCT07227376: Data Collection Using Eko Digital Devices in a Clinical Setting (Recruiting, started 2025-09-14)
- NCT07202104: Improvement of an Algorithm to Detect Structural Heart Murmurs in Adult Patients Using Electronic Stethoscopes (Recruiting, started 2025-09)
- NCT07270692: Detection of Reduced Left Ventricular Ejection Fraction With Three-Lead ECG Using Artificial Intelligence (Recruiting, started 2025-08-01)
- NCT07087613: Deep Learning Detection of Pulmonary Hypertension and Low Ejection Fraction Via Digital Stethoscope and 3-Lead ECG (Recruiting, started 2025-06-15)
Frequently asked questions
How many FDA 510(k) clearances does Eko Devices, Inc. have?
Eko Devices, Inc. has 6 FDA 510(k) clearances (first 2015, latest 2023), across 2 product codes in 1 review panel.
How long does FDA take to clear Eko Devices, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Eko Devices, Inc.'s cleared 510(k)s is 116 days. Since 2017: 129 days, versus 184 days for all cleared 510(k)s in the same product codes.
What devices does Eko Devices, Inc. make?
Its most frequent FDA product codes are DQD (Stethoscope, Electronic, 5); MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), 1).
Has Eko Devices, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Eko Devices, Inc. Related entities may recall under other names.
Next steps
- See all 6 Eko Devices, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQD, Eko Devices, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.