# Eko Devices, Inc.

- Location (FDA's records): Berkeley, CA
- FDA decisions: 6 (2015–2023): 6 510(k) clearances
- Product codes: DQD (5), MWI (1)
- 510(k) review time since 2016: median 129 days, against 132 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 9 (3 its own); citations of its devices by later devices: 19 (3 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
- Csd Labs GmbH: 1 (https://510kreport.com/company/csd-labs)
- Dictum Health, Inc.: 1 (https://510kreport.com/company/dictum-health)
- Diacoustic Medical Devices (Pty), Ltd.: 1 (https://510kreport.com/company/diacoustic-medical-devices)
- Inovise Medical, Inc.: 1 (https://510kreport.com/company/inovise-medical)
- Physiq, Inc.: 1 (https://510kreport.com/company/physiq)
- Tyto Care, Ltd.: 1 (https://510kreport.com/company/tyto-care)

## Firms that cite its devices most
- Eko Health, Inc.: 3 (https://510kreport.com/company/eko-health)
- Chip Ideas Electronics S.L.: 2 (https://510kreport.com/company/chip-ideas-electronics)
- Sparrow Acoustics, Inc.: 2 (https://510kreport.com/company/sparrow-acoustics)
- Smartsound Corporation: 1 (https://510kreport.com/company/smartsound)
- Homediagnostic, LLC: 1 (https://510kreport.com/company/homediagnostic)
- Shanghai Hulu Devices Co., Ltd.: 1 (https://510kreport.com/company/shanghai-hulu-devices)
- Coala Life AB: 1 (https://510kreport.com/company/coala-life)
- Gv Concepts: 1 (https://510kreport.com/company/gv-concepts)

## Its most-cited devices
- K200776: Eko CORE (2020), cited by 8
- K151319: Eko Electronic Stethoscope System (2015), cited by 4
- K170874: Eko Model E5 System (EME5), Eko DUO (2017), cited by 3
- K213794: Eko Murmur Analysis Software (EMAS) (2022), cited by 2
- K230111: CORE 500 Digital Stethoscope (2023), cited by 1
- K192004: Eko Analysis Software (2020), cited by 1

## Recent decisions
- K230111: CORE 500 Digital Stethoscope (May 26, 2023)
- K213794: Eko Murmur Analysis Software (EMAS) (Jun 29, 2022)
- K200776: Eko CORE (Apr 6, 2020)
- K192004: Eko Analysis Software (Jan 15, 2020)
- K170874: Eko Model E5 System (EME5), Eko DUO (May 19, 2017)
- K151319: Eko Electronic Stethoscope System (Aug 28, 2015)

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