Cleared Traditional

K921567 - COULTER MH017

K921567 is an FDA 510(k) clearance for COULTER MH017, manufactured by Coulter Electronics, Inc.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K921567 · Coulter Electronics, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
Jul 1992
Decision
95d
Days
Class 2
Risk

K921567 is an FDA 510(k) clearance for the COULTER MH017. 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 July 6, 1992 after a review of 95 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

FDA 510(k) Submission Details - K921567

510(k) Number K921567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1992
Decision Date July 06, 1992
Days to Decision 95 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 113d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKZ Device Classification - Class 2, Special Controls

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 295
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K921567.
TECHNICON H*2
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SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5
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SYSMEX HEMATOLOGY SYSTEM ACCESSORIES
K920544 · Toa Medical Electronics USA, Inc. · Apr 1992
SIMULTEST(TM) IMK-LYMPHOCYTE
K913192 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1992