# Calyxo, Inc.

- Location (FDA's records): Pleasanton, CA
- FDA decisions: 4 (2024–2026): 4 510(k) clearances
- Product codes: FED (2), FGB (2)
- 510(k) review time since 2016: median 80 days, against 119 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 5 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Fujirebio Diagnostics,Inc.: 1 (https://510kreport.com/company/fujirebio-diagnostics)
- Shanghai AnQing Medical Instrument Co., Ltd.: 1 (https://510kreport.com/company/shanghai-anqing-medical-instrument)

## Its most-cited devices
- K233472: CVAC Aspiration System + CVAC Image Processor (2024), cited by 3

## Recent decisions
- K261447: CVAC® Aspiration System (Sep 15, 2026)
- K260965: CVAC Aspiration System (Apr 13, 2026)
- K260013: CVAC Image Processor (Mar 6, 2026)
- K233472: CVAC Aspiration System + CVAC Image Processor (Feb 2, 2024)

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