Cleared Traditional

K854685 - DIGITAL-9 KEY LEUCOCYTE COUNTER (FDA 510(k) Clearance)

Class I Hematology device.

K854685 · Future Impex Corp. · Hematology device
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Apr 1986
Decision
135d
Days
Class 1
Risk

K854685 is an FDA 510(k) clearance for the DIGITAL-9 KEY LEUCOCYTE COUNTER. Classified as Hand-tally, Differential (product code GKM), Class I - General Controls.

Submitted by Future Impex Corp. (Deerpark, US). The FDA issued a Cleared decision on April 4, 1986 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6160 - 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 Future Impex Corp. devices

Submission Details

510(k) Number K854685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1985
Decision Date April 04, 1986
Days to Decision 135 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 113d · This submission: 135d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GKM Hand-tally, Differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.6160
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.