Cleared Traditional

K971236 - GREINER VACUETTE BLOOD COLLECTION TUBE

K971236 is the FDA 510(k) clearance for GREINER VACUETTE BLOOD COLLECTION TUBE by Greiner America, Inc.. It is a Class 2 Toxicology device (product code JKA) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K971236 · Greiner America, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
40d
Days
Class 2
Risk

K971236 is an FDA 510(k) clearance for the GREINER VACUETTE BLOOD COLLECTION TUBE. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Greiner America, Inc. (Lake Mary, US). The FDA issued a Cleared decision on May 12, 1997 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1675 - the FDA toxicology 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 Greiner America, Inc. devices

Submission Details

510(k) Number K971236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1997
Decision Date May 12, 1997
Days to Decision 40 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 87d · This submission: 40d
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 Toxicology devices follow this clearance model.

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

All 116
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K971236.
VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE
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SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STV
K974374 · Ohmeda Medical · Jan 1998
VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET
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PICO MODELS 30, 50, 70
K962158 · Radiometer America, Inc. · Oct 1996
MONOJECT(R) SAMPLETTE(R) COLLECTION TUBE
K944083 · Sherwood Medical Co. · May 1995