Cleared Traditional

SYSTEM 9000 AUTOMATED CELL COUNTER (K870603) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K870603 · Baker Instructions Corp. · Hematology device
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Mar 1987
Decision
48d
Days
Class 2
Risk

K870603 is an FDA 510(k) clearance for the SYSTEM 9000 AUTOMATED CELL COUNTER. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Baker Instructions Corp. (Winchester, US). The FDA issued a Cleared decision on March 31, 1987 after a review of 48 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Baker Instructions Corp. devices

Submission Details

510(k) Number K870603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1987
Decision Date March 31, 1987
Days to Decision 48 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 113d · This submission: 48d
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 129
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K870603.
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