Cleared Traditional

K222478 - BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device

K222478 is an FDA 510(k) clearance for BD Vacutainer Luer-Lok Access Device, manufactured by Becton, Dickinson and Company. The device is a Class 2 General Hospital device with product code JKA cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K222478 · Becton, Dickinson and Company · General Hospital
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Mar 2023
Decision
206d
Days
Class 2
Risk

K222478 is an FDA 510(k) clearance for the BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on March 10, 2023 after a review of 206 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 862.1675 - 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 Becton, Dickinson and Company devices

FDA 510(k) Submission Details - K222478

510(k) Number K222478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2022
Decision Date March 10, 2023
Days to Decision 206 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
77d slower than avg
Panel avg: 129d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JKA Device Classification - Class 2, Special Controls

Product Code JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
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 - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 164
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K222478.
Kurin Blood Culture Collection Set with Kurin Lock Technology
K220677 · Kurin, Inc. · Apr 2023
BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder
K220212 · Becton, Dickinson and Company · Mar 2023
Blood Collection Needle (with/without Needle Holder)
K223323 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · Mar 2023
Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)
K223810 · Sb-Kawasumi Laboratories, Inc. · Feb 2023
Safety Push Button Blood Collection Set
K222834 · Jiangsu Caina Medical Co.,Ltd · Jan 2023
Steripath Micro Blood Collection System
K222299 · Magnolia Medical Technologies · Nov 2022