Cleared Traditional

K231237 - BD Vacutainer Fluoride Blood Collection...

K231237 is an FDA 510(k) clearance for BD Vacutainer Fluoride Blood Collection..., manufactured by Becton, Dickinson and Company. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K231237 · Becton, Dickinson and Company · Chemistry device
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Optimized for regulatory review, auditing and printing
Jan 2024
Decision
266d
Days
Class 2
Risk

K231237 is an FDA 510(k) clearance for the BD Vacutainer® Fluoride Blood Collection Tubes. 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 January 19, 2024 after a review of 266 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K231237

510(k) Number K231237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2023
Decision Date January 19, 2024
Days to Decision 266 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
178d slower than avg
Panel avg: 88d · This submission: 266d
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 Chemistry 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 K231237.
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K231282 · Lifeoutcomes, LLC · Jan 2024
Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder
K232881 · Jiangsu Kangbao Medical Equipment Co., Ltd. · Dec 2023
BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes
K230855 · Becton, Dickinson and Company · Dec 2023
Monarch Blood Collection Set
K232308 · The Monarch Company · Dec 2023