Cleared Traditional

K850386 - SYSTEM 8000 CELL COUNTER

K850386 is the FDA 510(k) clearance for SYSTEM 8000 CELL COUNTER by Baker Instructions Corp.. It is a Class 2 Hematology device (product code GKL) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K850386 · Baker Instructions Corp. · Hematology device
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May 1985
Decision
90d
Days
Class 2
Risk

K850386 is an FDA 510(k) clearance for the SYSTEM 8000 CELL COUNTER. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Baker Instructions Corp. (Allentown, US). The FDA issued a Cleared decision on May 2, 1985 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5200 - 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 Baker Instructions Corp. devices

Submission Details

510(k) Number K850386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1985
Decision Date May 02, 1985
Days to Decision 90 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 113d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKL Counter, Cell, Automated (particle Counter)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5200
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 - GKL Counter, Cell, Automated (particle Counter)

All 57
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K850386.
COULTER COUNTER MODEL M5
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K851736 · Coulter Electronics, Inc. · Jul 1985
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K842346 · Coulter Electronics, Inc. · Jul 1984