# Cascination AG

- Location (FDA's records): Bern, CH
- FDA decisions: 8 (2015–2026): 8 510(k) clearances
- Product codes: QQE (4), JAK (3), OEW (1)
- 510(k) review time since 2016: median 167 days, against 141 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 8 (4 its own); citations of its devices by later devices: 5 (4 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
- Pathfinder Therapeutics, Inc.: 1 (https://510kreport.com/company/pathfinder-therapeutics)
- Perfint Healthcare Pvt, Ltd.: 1 (https://510kreport.com/company/perfint-healthcare-pvt)
- Veran Medical Technologies, Inc.: 1 (https://510kreport.com/company/veran-medical-technologies)
- Surgical Theater, LLC: 1 (https://510kreport.com/company/surgical-theater)

## Firms that cite its devices most
- Masmec Spa: 1 (https://510kreport.com/company/masmec)

## Its most-cited devices
- K152473: CAS-One IR (2016), cited by 2
- K203486: Otoplan (2021), cited by 2
- K232022: CAS-One IR (2024), cited by 1

## Recent decisions
- K262080: Otoplan (Oct 23, 2026)
- K261225: CAS-One IR (Sep 29, 2026)
- K242120: Otoplan (Apr 11, 2025)
- K232022: CAS-One IR (Mar 13, 2024)
- K220300: Otoplan (Jun 24, 2022)
- K203486: Otoplan (Aug 20, 2021)
- K152473: CAS-One IR (Jan 20, 2016)
- K143024: CAS-One Liver (Apr 28, 2015)

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