Cleared Traditional

K922445 - VACU-PRO

K922445 is an FDA 510(k) clearance for VACU-PRO, manufactured by Concord/Portex. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K922445 · Concord/Portex · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
82d
Days
Class 2
Risk

K922445 is an FDA 510(k) clearance for the VACU-PRO. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Concord/Portex (Keene, US). The FDA issued a Cleared decision on August 12, 1992 after a review of 82 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.

FDA 510(k) Submission Details - K922445

510(k) Number K922445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1992
Decision Date August 12, 1992
Days to Decision 82 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
6d faster than avg
Panel avg: 88d · This submission: 82d
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 208
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K922445.
VACUPLUS(R) STAR-SEP(TM)
K924363 · Starplex Scientific, Inc. · Feb 1993
VACUPLUS TUBES WITH BRICK RED STOPPERS
K924365 · Starplex Scientific, Inc. · Dec 1992
SAF-T HOLDER MULTI SAMPLE LUER ADAPTER W/ BLOOD
K923090 · Ryan Medical, Inc. · Sep 1992
VACUTAINER BRAND LUER ADAPTER
K921520 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1992
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
K922445 · VACU-PRO
Download PDF FDA Summary Concord/Portex