Cleared Traditional

K771107 - COUNTER 700 & HC-700 HEMO 0 REF.

K771107 is the FDA 510(k) clearance for COUNTER 700 & HC-700 HEMO 0 REF. by Hycel, Inc.. It is a Class 2 Hematology device (product code GKL) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K771107 · Hycel, Inc. · Hematology device
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Jul 1977
Decision
21d
Days
Class 2
Risk

K771107 is an FDA 510(k) clearance for the COUNTER 700 & HC-700 HEMO 0 REF.. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Hycel, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 11, 1977 after a review of 21 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 K771107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1977
Decision Date July 11, 1977
Days to Decision 21 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 113d · This submission: 21d
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 K771107.
COUNTER MODEL S PLUS BLOOD CELL COUNTER
K771512 · Coulter Electronics, Inc. · Nov 1977
AUTO. LEUCOCYTE DIFFER. ANALYZER D/90
K771728 · Technicon Instruments Corp. · Nov 1977
DETECTOTERGE AZIDE FREE
K771790 · J.T. Baker Chemical Co. · Oct 1977
HEMALOG 8/90
K770666 · Technicon Instruments Corp. · May 1977
LATELET DETERMIN. KIT, CAT NO. 2521
K770385 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1977
ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800)
K761289 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1977