Cleared Traditional

PuraCath Firefly Needleless Connector IT (9005)

K251375 · Puracath Medical, Inc. · General Hospital
Feb 2026
Decision
286d
Days
Class 2
Risk

About This 510(k) Submission

K251375 is an FDA 510(k) clearance for the PuraCath Firefly Needleless Connector IT (9005), a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Puracath Medical, Inc. (Newark, US). The FDA issued a Cleared decision on February 12, 2026, 286 days after receiving the submission on May 2, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K251375 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2025
Decision Date February 12, 2026
Days to Decision 286 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

Similar Devices — FPA Set, Administration, Intravascular

All 1173
nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]
K251257 · Np Medical · Dec 2025
BD Alaris Pump Infusion Set
K250325 · Carefusion (Bd) · Oct 2025
EZ? IV Administration Set
K251814 · Epic Medical Pte. , Ltd. · Aug 2025
SteadiSet infusion set
K251854 · Tandem Diabetes Care · Aug 2025
Sparta Infusion Set for Insulin
K243841 · Deka Research and Development · Aug 2025
Infusomat? Space Volumetric Infusion Pump Administration Sets
K243392 · B.Braun Medical, Inc. · Jul 2025