Cleared Traditional

VACUTAINER BRAND LUER ADAPTER (K921520) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K921520 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
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Jul 1992
Decision
101d
Days
Class 2
Risk

K921520 is an FDA 510(k) clearance for the VACUTAINER BRAND LUER ADAPTER. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on July 10, 1992 after a review of 101 days - within the typical 510(k) review window.

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.

View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K921520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1992
Decision Date July 10, 1992
Days to Decision 101 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 88d · This submission: 101d
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 Chemistry devices follow this clearance model.

Regulatory Peers - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 96
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K921520.
MICROTAINER BRAND TUBE WITH EDTA(K2)
K940905 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1994
MICROTAINER BRAND TUBE WITH EDTA
K931368 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1993
VACUTAINER BRAND LUER ADAPTER
K931367 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1993
VACUTAINER(R) BRAND SST(R) AND CAT TUBES
K921806 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
QBC E-Z PREP
K913399 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1991
VACUTAINER PLUS WITH HEMOGARD CLOSURE
K901449 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990