# Eko Health, Inc.

- Location (FDA's records): Emeryville, CA
- FDA decisions: 4 (2024–2026): 4 510(k) clearances
- Product codes: DQD (3), QYE (1)
- 510(k) review time since 2016: median 89 days, against 153 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Eko Devices, Inc.: 3 (https://510kreport.com/company/eko-devices)
- Anumana, Inc.: 1 (https://510kreport.com/company/anumana)

## Recent decisions
- K261694: CORE 300 Digital Stethoscope (Jul 23, 2026)
- K251494: Eko Foundation Analysis Software with Transformers (EFAST) (Aug 12, 2025)
- K233409: Eko Low Ejection Fraction Tool (ELEFT) (Mar 28, 2024)
- K233609: CORE 500 Digital Stethoscope (Mar 28, 2024)

Source page: https://510kreport.com/company/eko-health