Cleared Traditional

K922181 - COULTER MH009

K922181 is the FDA 510(k) clearance for COULTER MH009 by Coulter Electronics, Inc.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K922181 · Coulter Electronics, Inc. · Hematology device
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Aug 1992
Decision
101d
Days
Class 2
Risk

K922181 is an FDA 510(k) clearance for the COULTER MH009. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on August 17, 1992 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Coulter Electronics, Inc. devices

Submission Details

510(k) Number K922181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1992
Decision Date August 17, 1992
Days to Decision 101 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 113d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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 Hematology devices follow this clearance model.

Regulatory Peers - GKZ Counter, Differential Cell

All 193
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K922181.
COULTER NEW METH BLUE PREPREP RETIC/MAXM W/AUTOLOA
K925344 · Coulter Corp. · Jan 1993
CD4 CYTOSPHERES KIT
K921279 · Coulter Electronics, Inc. · Dec 1992
TECHNICON H*2
K923237 · Heraeus Kulzer, Inc. · Sep 1992
COULTER MAXM W/ AUTOLOADER
K922704 · Coulter Electronics, Inc. · Jul 1992
COULTER MH017
K921567 · Coulter Electronics, Inc. · Jul 1992
SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5
K920949 · Heraeus Kulzer, Inc. · May 1992