Cleared Traditional

K242320 - BD Vacutainer One Use Holder

K242320 is the FDA 510(k) clearance for BD Vacutainer One Use Holder by Becton, Dickinson and Company. It is a Class 2 General Hospital device (product code JKA) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K242320 · Becton, Dickinson and Company · General Hospital
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Nov 2024
Decision
88d
Days
Class 2
Risk

K242320 is an FDA 510(k) clearance for the BD Vacutainer® One Use Holder. 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 November 1, 2024 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Becton, Dickinson and Company devices

Submission Details

510(k) Number K242320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2024
Decision Date November 01, 2024
Days to Decision 88 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
41d faster than avg
Panel avg: 129d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 115
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K242320.
Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set
K250907 · Sol-Millennium Medical, Inc. · Apr 2025
BD Vacutainer® Multiple Sample Luer Adapter
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PIVO™ Pro Needle-free Blood Collection Device
K241586 · Becton Dickinson Infusion Therapy Systems, Inc. · Feb 2025
VACUETTE® QUICKSHIELD Complete (Plus)
K233979 · Greiner Bio-One North America, Inc. · Jul 2024
Safety Sliding Blood Collection Set
K232781 · Jiangsu Caina Medical Co.,Ltd · Mar 2024
BD Vacutainer® K2 EDTA Blood Collection Tubes
K231373 · Becton, Dickinson and Company · Feb 2024