Cleared Traditional

K885093 - COULTER STKS

K885093 is an FDA 510(k) clearance for COULTER STKS, 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 19-day FDA review.

K885093 · Coulter Electronics, Inc. · Hematology device
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Dec 1988
Decision
19d
Days
Class 2
Risk

K885093 is an FDA 510(k) clearance for the COULTER STKS. 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 December 28, 1988 after a review of 19 days - a notably fast clearance cycle.

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: 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 - K885093

510(k) Number K885093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1988
Decision Date December 28, 1988
Days to Decision 19 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 113d · This submission: 19d
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 380
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K885093.
COULTER CLONE T3 MONOCLONAL ANTIBODY
K883710 · Coulter Immunology · Feb 1989
COULTER CLONE T1 MONOCLONAL ANTIBODY
K883753 · Coulter Immunology · Feb 1989
COULTER CLONE B4 MONOCLONAL ANTIBODY
K884020 · Coulter Immunology · Feb 1989
CYTO-STAT/COULTER CLONE T11-RD1/B1-FITC MONO. ANTI
K884346 · Coulter Immunology · Dec 1988
SYSMEX NE-8000
K883997 · Toa Medical Electronics USA, Inc. · Dec 1988
HEMAT 12
K884006 · Texas Intl. Laboratories, Inc. · Dec 1988
K885093 · COULTER STKS
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