Cleared Traditional

K912133 - PX COULTER(R) CELL CONTROL (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K912133 · Coulter Electronics, Inc. · Hematology device
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Jul 1991
Decision
64d
Days
Class 2
Risk

K912133 is an FDA 510(k) clearance for the PX COULTER(R) CELL CONTROL. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on July 17, 1991 after a review of 64 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 Coulter Electronics, Inc. devices

Submission Details

510(k) Number K912133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1991
Decision Date July 17, 1991
Days to Decision 64 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 113d · This submission: 64d
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.