Cleared Traditional

FLUID ADMINISTRATION LINE W/SPIKE 14-923

K842858 · Norton Performance Plastics Corp. · General Hospital
Sep 1984
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K842858 is an FDA 510(k) clearance for the FLUID ADMINISTRATION LINE W/SPIKE 14-923, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Norton Performance Plastics Corp. (Mchenry, US). The FDA issued a Cleared decision on September 11, 1984, 50 days after receiving the submission on July 23, 1984. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K842858 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 1984
Decision Date September 11, 1984
Days to Decision 50 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

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