# Sonio

- Location (FDA's records): Paris, FR
- FDA decisions: 5 (2023–2026): 5 510(k) clearances
- Product codes: IYN (3), POK (2)
- 510(k) review time since 2016: median 91 days, against 119 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 5 (3 its own); citations of its devices by later devices: 7 (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
- Koios Medical, Inc.: 1 (https://510kreport.com/company/koios-medical)
- GE Medical Systems Ultrasound and Primary Care Diagnostics: 1 (https://510kreport.com/company/ge-medical-systems-ultrasound-and-primary-care-diagnostics)

## Firms that cite its devices most
- Bioticsai, Inc.: 1 (https://510kreport.com/company/bioticsai)
- Deepecho: 1 (https://510kreport.com/company/deepecho)
- Diagnoly: 1 (https://510kreport.com/company/diagnoly)
- Clarius Mobile Health Corp.: 1 (https://510kreport.com/company/clarius-mobile-health)

## Its most-cited devices
- K240406: Sonio Detect (2024), cited by 3
- K230365: Sonio Detect (2023), cited by 3
- K243614: Sonio Suspect (2025), cited by 1

## Recent decisions
- K261519: Sonio Suspect (Jun 4, 2026)
- K252433: Sonio Detect  (v3) (Mar 16, 2026)
- K243614: Sonio Suspect (Feb 21, 2025)
- K240406: Sonio Detect (Apr 26, 2024)
- K230365: Sonio Detect (Jul 25, 2023)

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