# K251375: PuraCath Firefly Needleless Connector IT (9005)

- Pathway: 510(k) (Traditional)
- Applicant: Puracath Medical, Inc.
- Decided: Feb 12, 2026 after 286 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K942988 (1995). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203796: Firefly Needleless Connector, Puracath Medical, Inc. (2021) Summary page 6.

## Indications for use
The PuraCath™ Firefly™ Needleless Connector IT is a sterile single patient use connector for needleless access to the IV line and/or IV catheter during IV therapy and can be used for direct injection, intermittent infusion, continuous infusion or aspiration.

Source page: https://510kreport.com/device/K251375
Methodology: https://510kreport.com/methodology