Cleared Traditional

K971239 - GREINER VACUETTE BLOOD COLLECTION TUBE

K971239 is an FDA 510(k) clearance for GREINER VACUETTE BLOOD COLLECTION TUBE, manufactured by Greiner America, Inc.. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K971239 · Greiner America, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
40d
Days
Class 2
Risk

K971239 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 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: 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

FDA 510(k) Submission Details - K971239

510(k) Number K971239 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 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
48d faster than avg
Panel avg: 88d · This submission: 40d
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 143
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K971239.
TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER
K971111 · Tri-Tech, Inc. · Jun 1997
GREINER VACUETTE BLOOD COLLECTION TUBE
K971220 · Greiner America, Inc. · Jun 1997
GREINER VACUETTE BLOOD COLLECTION TUBE
K971236 · Greiner America, Inc. · May 1997
SAFETEX COMBINATION BLOOD (ALCOHOL, ETHYL) / URINE COLLECTION AND TRANSPORT KIT
K964698 · Andwin Scientific · Mar 1997
VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET
K965202 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1997
PICO MODELS 30, 50, 70
K962158 · Radiometer America, Inc. · Oct 1996