Cleared Traditional

BD SmartSite? 13mm Vial Access Device; BD SmartSite? 20mm Vial Access Device

K233021 · Care Fusion · General Hospital
Mar 2024
Decision
166d
Days
Class 2
Risk

About This 510(k) Submission

K233021 is an FDA 510(k) clearance for the BD SmartSite? 13mm Vial Access Device; BD SmartSite? 20mm Vial Access Device, a Set, I.v. Fluid Transfer (Class II — Special Controls, product code LHI), submitted by Care Fusion (San Diego, US). The FDA issued a Cleared decision on March 6, 2024, 166 days after receiving the submission on September 22, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K233021 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2023
Decision Date March 06, 2024
Days to Decision 166 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