Cleared Special

PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP

K121032 · Hospira, Inc. · General Hospital
Jun 2012
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K121032 is an FDA 510(k) clearance for the PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on June 21, 2012, 77 days after receiving the submission on April 5, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K121032 FDA.gov
FDA Decision Cleared SESE
Date Received April 05, 2012
Decision Date June 21, 2012
Days to Decision 77 days
Submission Type Special
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