Cleared Traditional

K233021 - BD SmartSite™ 13mm Vial Access Device

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

K233021 is an FDA 510(k) clearance for BD SmartSite 13mm Vial Access Device, manufactured by Care Fusion. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K233021

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.

LHI Device Classification - Class 2, Special Controls

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 127
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