Cleared Traditional

K782101 - HYCEL COUNTER 222

K782101 is the FDA 510(k) clearance for HYCEL COUNTER 222 by Hycel, Inc.. It is a Class 2 Hematology device (product code GKL) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K782101 · Hycel, Inc. · Hematology device
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Jan 1979
Decision
16d
Days
Class 2
Risk

K782101 is an FDA 510(k) clearance for the HYCEL COUNTER 222. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Hycel, Inc. (Walker, US). The FDA issued a Cleared decision on January 3, 1979 after a review of 16 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 Hycel, Inc. devices

Submission Details

510(k) Number K782101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1978
Decision Date January 03, 1979
Days to Decision 16 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 113d · This submission: 16d
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 76
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K782101.
TECHNICON H6000 HEMATOLOGY SYSTEM
K801155 · Technicon Instruments Corp. · Jun 1980
COULTER COUNTER MODEL S PLUS
K792537 · Coulter Electronics, Inc. · Jan 1980
COULTER COUNTER-BLOOD CELL COUNTER
K792668 · Coulter Electronics, Inc. · Jan 1980
HEMO-W SYSTEM
K781628 · Coulter Electronics, Inc. · Oct 1978
SYSMEX AUTO. BLOOD CELL COUNTER, CC-120
K780909 · Toa Medical Electronics USA, Inc. · Jun 1978
SYSTEM AUTO. BLOOD CELL COUNTER CC-110
K780910 · Toa Medical Electronics USA, Inc. · Jun 1978