Cleared Traditional

ADD-VANTAGE ADDAPTOR

K133602 · Hospira, Inc. · General Hospital
Jan 2014
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K133602 is an FDA 510(k) clearance for the ADD-VANTAGE ADDAPTOR, a Set, I.v. Fluid Transfer (Class II — Special Controls, product code LHI), submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on January 24, 2014, 60 days after receiving the submission on November 25, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K133602 FDA.gov
FDA Decision Cleared SESE
Date Received November 25, 2013
Decision Date January 24, 2014
Days to Decision 60 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LHI — Set, I.v. Fluid Transfer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

Similar Devices — LHI Set, I.v. Fluid Transfer

All 204
Medline Bag Decanter
K250345 · Medline Industries, LP · Oct 2025
FlowArt? Vial Access Device Vented
K251715 · Asset Medikal · Oct 2025
Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)
K251676 · Microtek Medical, LLC · Sep 2025
HyHub? and HyHub? Duo Vial Access Devices
K243404 · Takeda Pharmaceuticals · Jul 2025
Arisure? Closed Male Luer with Spike Adapter (YM060)
K240761 · Yukon Medical, LLC · Mar 2025
Rio? Drug Reconstitution Transfer Device
K243985 · Icu Medical, Inc. · Jan 2025