Cleared Traditional

K822445 - HCT CENTRIFUGE

K822445 is an FDA 510(k) clearance for HCT CENTRIFUGE, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Chemistry device with product code GKG cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K822445 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1982
Decision
29d
Days
Class 2
Risk

K822445 is an FDA 510(k) clearance for the HCT CENTRIFUGE. Classified as Centrifuge, Hematocrit (product code GKG), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1982 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.6400 - 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K822445

510(k) Number K822445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1982
Decision Date September 14, 1982
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 88d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKG Device Classification - Class 2, Special Controls

Product Code GKG Centrifuge, Hematocrit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6400
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 - GKG Centrifuge, Hematocrit

Devices cleared under the same product code (GKG) and FDA review panel - the closest regulatory comparables to K822445.
MICROHEMATOCRIT ROTOR
K930415 · Fisher Scientific Co., LLC · Mar 1993
SPUNCRIT
K925863 · bioMerieux, Inc. · Feb 1993
QBC CENTRIFUGAL HEMATOLOGY SYSTEM
K821803 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1982
CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY
K813033 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1982