# Cytovale, Inc.

- Location (FDA's records): South San Francisco, CA
- FDA decisions: 3 (2022–2025): 3 510(k) clearances
- Product codes: QUT (3)
- Predicates its devices cite: 3 (2 its own); citations of its devices by later devices: 2 (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
- bioMerieux, Inc.: 1 (https://510kreport.com/company/biomerieux)

## Its most-cited devices
- K220991: IntelliSep test (2022), cited by 2

## Recent decisions
- K250912: IntelliSep Test (Nov 19, 2025)
- K250513: IntelliSep Test (CV-ICG-048) (Mar 21, 2025)
- K220991: IntelliSep test (Dec 20, 2022)

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