FDA applicant
Eko Health, Inc.
FDA records 4 decisions for Eko Health, Inc. (Emeryville, CA) from 2024 to 2026: 4 510(k) clearances. Most are in product codes DQD (Stethoscope, Electronic) and QYE (Reduced Ejection Fraction Machine…). Since 2016 its 510(k)s took a median of 89 days from receipt to decision, against 153 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Eko Health, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like Eko Health, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report