Cleared Traditional

BD Secondary Infusion Set

K223101 · Care Fusion · General Hospital
May 2023
Decision
224d
Days
Class 2
Risk

About This 510(k) Submission

K223101 is an FDA 510(k) clearance for the BD Secondary Infusion Set, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Care Fusion (San Diego, US). The FDA issued a Cleared decision on May 12, 2023, 224 days after receiving the submission on September 30, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K223101 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2022
Decision Date May 12, 2023
Days to Decision 224 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
PuraCath Firefly Needleless Connector IT (9005)
K251375 · Puracath Medical, Inc. · Feb 2026
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