Cleared Traditional

K760765 - WHOLE BLOOD PLATELET COUNTER -2510

K760765 is the FDA 510(k) clearance for WHOLE BLOOD PLATELET COUNTER -2510 by Clay Adams, Div. Becton Dickinson & Co.. It is a Class 2 Hematology device (product code GKL) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K760765 · Clay Adams, Div. Becton Dickinson & Co. · Hematology device
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Dec 1976
Decision
87d
Days
Class 2
Risk

K760765 is an FDA 510(k) clearance for the WHOLE BLOOD PLATELET COUNTER -2510. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Clay Adams, Div. Becton Dickinson & Co. (Mchenry, US). The FDA issued a Cleared decision on December 30, 1976 after a review of 87 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 Clay Adams, Div. Becton Dickinson & Co. devices

Submission Details

510(k) Number K760765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1976
Decision Date December 30, 1976
Days to Decision 87 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 113d · This submission: 87d
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 83
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K760765.
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
COUNTER, BLOOD CELL & HEMATOCRIT
K770034 · Mallinckrodt Critical Care · Feb 1977
HA/3 HEMATOLOGY ANALYZER
K760582 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1976
HA/5 HEMATOLOGY ANALYZER
K760581 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1976