Cleared Traditional

EXTENSION SET, MODELS 1911-512

K020926 · Epimed International, Inc. · General Hospital
Jul 2002
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K020926 is an FDA 510(k) clearance for the EXTENSION SET, MODELS 1911-512, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Epimed International, Inc. (Johnstown, US). The FDA issued a Cleared decision on July 12, 2002, 113 days after receiving the submission on March 21, 2002. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K020926 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 2002
Decision Date July 12, 2002
Days to Decision 113 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