Cleared Traditional

K974873 - VACUETTE (MULTI-USE HOLDER)

K974873 is an FDA 510(k) clearance for VACUETTE (MULTI-USE HOLDER), 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 38-day FDA review.

K974873 · Greiner Meditech, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
38d
Days
Class 2
Risk

K974873 is an FDA 510(k) clearance for the VACUETTE (MULTI-USE HOLDER). 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 February 5, 1998 after a review of 38 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 - K974873

510(k) Number K974873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1997
Decision Date February 05, 1998
Days to Decision 38 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
50d faster than avg
Panel avg: 88d · This submission: 38d
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 K974873.
VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE
K981013 · Becton Dickinson Vacutainer Systems · Jun 1998
PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES
K981035 · Sims Portex, Inc. · Apr 1998
VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SET
K980414 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1998
VACUTAINER BRAND PRONTO NEEDLES HOLDER
K980098 · Becton Dickinson Vacutainer Systems · Feb 1998
SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STV
K974374 · Ohmeda Medical · Jan 1998
TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER
K971111 · Tri-Tech, Inc. · Jun 1997