Cleared Traditional

K954688 - FLOW-COUNT COULTER FLUOROSPHERES

K954688 is an FDA 510(k) clearance for FLOW-COUNT COULTER FLUOROSPHERES, manufactured by Coulter Corp.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K954688 · Coulter Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
141d
Days
Class 2
Risk

K954688 is an FDA 510(k) clearance for the FLOW-COUNT COULTER FLUOROSPHERES. 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 February 29, 1996 after a review of 141 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

FDA 510(k) Submission Details - K954688

510(k) Number K954688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1995
Decision Date February 29, 1996
Days to Decision 141 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 113d · This submission: 141d
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 K954688.
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