Cleared Traditional

K950949 - COULTER MH025A

K950949 is the FDA 510(k) clearance for COULTER MH025A by Coulter Corp.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K950949 · Coulter Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
140d
Days
Class 2
Risk

K950949 is an FDA 510(k) clearance for the COULTER MH025A. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Coulter Corp. (Miami, US). The FDA issued a Cleared decision on July 20, 1995 after a review of 140 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 Corp. devices

Submission Details

510(k) Number K950949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1995
Decision Date July 20, 1995
Days to Decision 140 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
27d slower than avg
Panel avg: 113d · This submission: 140d
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 K950949.
ROCHE COBAS MICROS HEMATOLOGY ANALYZER
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OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES
K950626 · Immunotech Corp. · May 1995
ORTHO-MUNE OKT 3 MONOCLONAL ANTIBODY (MURINE)
K932530 · Ortho Diagnostic Systems, Inc. · Apr 1995
ORTHO-MUNE OKT 4 (CD4) MONOCLONAL ANTIBODY MURINE
K932531 · Ortho Diagnostic Systems, Inc. · Apr 1995