Cleared Traditional

K992244 - GREINER MINICOLLECT COAGULATION BLOOD COLLECTION TUBE

K992244 is an FDA 510(k) clearance for GREINER MINICOLLECT COAGULATION BLOOD C..., manufactured by Greiner Meditech, Inc.. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K992244 · Greiner Meditech, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
24d
Days
Class 2
Risk

K992244 is an FDA 510(k) clearance for the GREINER MINICOLLECT COAGULATION BLOOD COLLECTION TUBE. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Greiner Meditech, Inc. (Bel Air, US). The FDA issued a Cleared decision on July 26, 1999 after a review of 24 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 Meditech, Inc. devices

FDA 510(k) Submission Details - K992244

510(k) Number K992244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1999
Decision Date July 26, 1999
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 88d · This submission: 24d
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 144
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K992244.
BD VACUTAINER PLUS PST II TUBE
K022130 · Becton, Dickinson & CO · Jul 2002
BD VACUTAINER SAFETY COAGULATION TUBE
K013971 · Becton, Dickinson & CO · Feb 2002
VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE
K991551 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1999
GREINER VACUETTE BLOOD COLLECTION TUBE
K983952 · Greiner Meditech, Inc. · Dec 1998
TERUMO VENOJECT,LUER ADAPTER
K983490 · Terumo Corp. · Nov 1998
SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM
K983517 · Ram Scientific · Nov 1998