# Sonavex, Inc.

- Location (FDA's records): Baltimore, MD
- FDA decisions: 3 (2018–2025): 3 510(k) clearances
- Product codes: IYO (2), NEU (1)
- 510(k) review time since 2016: median 89 days, against 89 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 1 (1 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
- Analogic Corp.: 1 (https://510kreport.com/company/analogic)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)
- Focal Therapeutics: 1 (https://510kreport.com/company/focal-therapeutics)
- Winprobe Corporation: 1 (https://510kreport.com/company/winprobe)

## Its most-cited devices
- K190039: EchoSure Diagnostic Ultrasound System (2019), cited by 1

## Recent decisions
- K243479: EchoGuide (Version 1) (Apr 23, 2025)
- K190039: EchoSure Diagnostic Ultrasound System (Mar 8, 2019)
- K180621: EchoMark, EchoMark LP (Jun 6, 2018)

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