Cleared Traditional

K233021 - BD SmartSite™ 13mm Vial Access Device (FDA 510(k) Clearance)

Also includes:
BD SmartSite™ 20mm Vial Access Device

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233021 · Care Fusion · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
166d
Days
Class 2
Risk

K233021 is an FDA 510(k) clearance for the BD SmartSite™ 13mm Vial Access Device. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Care Fusion (San Diego, US). The FDA issued a Cleared decision on March 6, 2024 after a review of 166 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Care Fusion devices

Submission Details

510(k) Number K233021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 128d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LHI Set, I.v. Fluid Transfer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LHI Set, I.v. Fluid Transfer

All 204
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K233021.
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)
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