Cleared Traditional

K233021 - BD SmartSite 13mm Vial Access Device

Also marketed or referenced as:
BD SmartSite™ 20mm Vial Access Device

K233021 is the FDA 510(k) clearance for BD SmartSite 13mm Vial Access Device by Care Fusion. It is a Class 2 General Hospital device (product code LHI) cleared through the Traditional 510(k) pathway after a 166-day FDA review.

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
37d slower than avg
Panel avg: 129d · 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 71
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K233021.
Vial2Bag Advanced® 20mm Admixture Device
K240940 · West Pharmaceutical Services, Inc. · May 2024
Vial Adapter with Filter
K233284 · Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · May 2024
nextaro® v, 20/20
K240748 · Sfm Medical Devices GmbH · Apr 2024
Mix2Vial® Transfer Device
K231071 · West Pharma Services Il, Ltd. · Jan 2024
Vial Adapter 20mm
K232875 · West Pharma Services Il, Ltd. · Dec 2023
Vial2Bag Advanced® 13mm Admixture Device
K230988 · West Pharma Services Il, Ltd. · Dec 2023