Cleared Traditional

Sparta Infusion Set for Insulin

K243841 · Deka Research and Development · Chemistry
Aug 2025
Decision
231d
Days
Class 2
Risk

About This 510(k) Submission

K243841 is an FDA 510(k) clearance for the Sparta Infusion Set for Insulin, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Deka Research and Development (Manchester, US). The FDA issued a Cleared decision on August 1, 2025, 231 days after receiving the submission on December 13, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K243841 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2024
Decision Date August 01, 2025
Days to Decision 231 days
Submission Type Traditional
Review Panel Chemistry (CH)
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
Infusomat? Space Volumetric Infusion Pump Administration Sets
K243392 · B.Braun Medical, Inc. · Jul 2025