# Puracath Medical, Inc.

- Location (FDA's records): Newark, CA
- FDA decisions: 3 (2016–2026): 3 510(k) clearances
- Product codes: FPA (2), KDJ (1)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 1 (1 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
- Baxter Healthcare Corp: 1 (https://510kreport.com/company/baxter-healthcare)
- Catheter Connections, Inc.: 1 (https://510kreport.com/company/catheter-connections)
- Care Fusion: 1 (https://510kreport.com/company/care-fusion)

## Its most-cited devices
- K203796: Firefly Needleless Connector (2021), cited by 1

## Recent decisions
- K251375: PuraCath Firefly Needleless Connector IT (9005) (Feb 12, 2026)
- K203796: Firefly Needleless Connector (Jul 30, 2021)
- K151620: Firefly Peritoneal Dialysis Connector Disinfection System (Jan 20, 2016)

Source page: https://510kreport.com/company/puracath-medical