Cleared Traditional

K802265 - CBC PLT-4

K802265 is the FDA 510(k) clearance for CBC PLT-4 by R&D Systems, Inc.. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K802265 · R&D Systems, Inc. · Hematology device
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Nov 1980
Decision
57d
Days
Class 2
Risk

K802265 is an FDA 510(k) clearance for the CBC PLT-4. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by R&D Systems, Inc. (Walker, US). The FDA issued a Cleared decision on November 12, 1980 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - 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 R&D Systems, Inc. devices

Submission Details

510(k) Number K802265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1980
Decision Date November 12, 1980
Days to Decision 57 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
56d faster than avg
Panel avg: 113d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPK Mixture, Hematology Quality Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
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 - JPK Mixture, Hematology Quality Control

All 133
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K802265.
HEMOTOLOGY QUALITY CONTROL MIXTURE
K812237 · American Dade · Sep 1981
HEMATOLOGY CONTROL
K812280 · American Dade · Sep 1981
VENTREX DATA REDUCTION & QUAL. CONTR. SY
K812357 · Ventrex Laboratories, Inc. · Sep 1981
PLT-4 SIZE-CHECK
K802267 · R&D Systems, Inc. · Nov 1980
CH-60 PLUS WHOLE BLOOD PLATELET CONTROL
K802141 · American Dade · Oct 1980
CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL
K802142 · American Dade · Oct 1980