# Bioserenity Sas

- Location (FDA's records): Paris, FR
- FDA decisions: 5 (2017–2023): 5 510(k) clearances
- Names in FDA's records: Bioserenity Sas (3); Bioserenity (2)
- Product codes: GWQ (4), DXH (1)
- 510(k) review time since 2016: median 182 days, against 181 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 7 (2 its own); citations of its devices by later devices: 4 (2 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
- Nanowear, Inc.: 1 (https://510kreport.com/company/nanowear)
- Healthwatch, Ltd.: 1 (https://510kreport.com/company/healthwatch)
- Nihon Kohden Corporation: 1 (https://510kreport.com/company/nihon-kohden)
- Advanced Brain Monitoring, Inc.: 1 (https://510kreport.com/company/advanced-brain-monitoring)
- Rhythmlink International, LLC: 1 (https://510kreport.com/company/rhythmlink-international)

## Firms that cite its devices most
- Bioserenity Medical Devices Group: 1 (https://510kreport.com/company/bioserenity-medical-devices-group)
- Ceribell, Inc.: 1 (https://510kreport.com/company/ceribell)

## Its most-cited devices
- K202334: Neuronaute (2020), cited by 2
- K223644: Neuronaute with IceCap 2 & IceCap 2 Small (2023), cited by 1
- K231366: Neuronaute Plus (2023), cited by 1

## Recent decisions
- K231366: Neuronaute Plus (Nov 9, 2023)
- K223644: Neuronaute with IceCap 2 & IceCap 2 Small (Jan 12, 2023)
- K202334: Neuronaute (Dec 10, 2020)
- K173248: Cardioskin (Aug 11, 2018)
- K170138: Neuronaute (Dec 26, 2017)

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