# EchoNous, Inc.

- Location (FDA's records): Redmond, WA
- FDA decisions: 5 (2018–2025): 5 510(k) clearances
- Product codes: IYN (4), IYO (1)
- 510(k) review time since 2016: median 98 days, against 105 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Signostics Pty, Ltd.: 1 (https://510kreport.com/company/signostics)
- GE Medical Systems Ultrasound and Primary Care Diagnostics: 1 (https://510kreport.com/company/ge-medical-systems-ultrasound-and-primary-care-diagnostics)
- Eko Devices, Inc.: 1 (https://510kreport.com/company/eko-devices)

## Firms that cite its devices most
- Philips Ultrasound, Inc.: 1 (https://510kreport.com/company/philips-ultrasound)

## Its most-cited devices
- K193518: Kosmos (2020), cited by 1
- K233826: Kosmos (2024), cited by 1

## Recent decisions
- K242321: Kosmos (Apr 25, 2025)
- K233826: Kosmos (Aug 29, 2024)
- K212100: Kosmos (Aug 6, 2021)
- K193518: Kosmos (Mar 26, 2020)
- K181574: Uscan (Jul 10, 2018)

Source page: https://510kreport.com/company/echonous