Cleared Traditional

K830507 - SYSMEX CC-170

K830507 is the FDA 510(k) clearance for SYSMEX CC-170 by Toa Medical Electronics USA, Inc.. It is a Class 2 Hematology device (product code GKL) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K830507 · Toa Medical Electronics USA, Inc. · Hematology device
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May 1983
Decision
85d
Days
Class 2
Risk

K830507 is an FDA 510(k) clearance for the SYSMEX CC-170. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Toa Medical Electronics USA, Inc. (Walker, US). The FDA issued a Cleared decision on May 13, 1983 after a review of 85 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 Toa Medical Electronics USA, Inc. devices

Submission Details

510(k) Number K830507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1983
Decision Date May 13, 1983
Days to Decision 85 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
28d faster than avg
Panel avg: 113d · This submission: 85d
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 68
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K830507.
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K830506 · Toa Medical Electronics USA, Inc. · May 1983
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K830508 · Toa Medical Electronics USA, Inc. · May 1983