Cleared Traditional

K243649 - BD Vacutainer® Multiple Sample Luer Adapter

K243649 is an FDA 510(k) clearance for BD Vacutainer Multiple Sample Luer Adapter, 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 115-day FDA review.

K243649 · Becton, Dickinson and Company · General Hospital
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Optimized for regulatory review, auditing and printing
Mar 2025
Decision
115d
Days
Class 2
Risk

K243649 is an FDA 510(k) clearance for the BD Vacutainer® Multiple Sample Luer Adapter. 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 21, 2025 after a review of 115 days - within the typical 510(k) review window.

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 - K243649

510(k) Number K243649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2024
Decision Date March 21, 2025
Days to Decision 115 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
14d faster than avg
Panel avg: 129d · This submission: 115d
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 K243649.
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Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)
K244047 · Venocare, Inc. · May 2025
Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set
K250907 · Sol-Millennium Medical, Inc. · Apr 2025
PIVO™ Pro Needle-free Blood Collection Device
K241586 · Becton Dickinson Infusion Therapy Systems, Inc. · Feb 2025
BD Vacutainer® One Use Holder
K242320 · Becton, Dickinson and Company · Nov 2024
VACUETTE® QUICKSHIELD Complete (Plus)
K233979 · Greiner Bio-One North America, Inc. · Jul 2024