Cleared Traditional

K212724 - BD Vacutainer UltraTouch Push Button Bl...

K212724 is an FDA 510(k) clearance for BD Vacutainer UltraTouch Push Button Bl..., 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 161-day FDA review.

K212724 · Becton, Dickinson and Company · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 2022
Decision
161d
Days
Class 2
Risk

K212724 is an FDA 510(k) clearance for the BD Vacutainer UltraTouch Push Button Blood Collection Set. 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 February 4, 2022 after a review of 161 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 - K212724

510(k) Number K212724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2021
Decision Date February 04, 2022
Days to Decision 161 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
32d slower than avg
Panel avg: 129d · This submission: 161d
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 119
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K212724.
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