Cleared Traditional

K955334 - COULTER LINEARITY CONTROL

K955334 is the FDA 510(k) clearance for COULTER LINEARITY CONTROL by Coulter Corp.. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K955334 · Coulter Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
80d
Days
Class 2
Risk

K955334 is an FDA 510(k) clearance for the COULTER LINEARITY CONTROL. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Coulter Corp. (Miami, US). The FDA issued a Cleared decision on February 8, 1996 after a review of 80 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 Corp. devices

Submission Details

510(k) Number K955334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1995
Decision Date February 08, 1996
Days to Decision 80 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
33d faster than avg
Panel avg: 113d · This submission: 80d
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 K955334.
CBC-4K HEMATOLOGY CONTROL
K970331 · R&D Systems, Inc. · Apr 1997
R&D RETIC-PG HEMATOLOGY CONTROL
K961673 · R&D Systems, Inc. · Jul 1996
CALIBRATION VERIFICATION ASSESSMENT (CVA)
K960557 · Streck Laboratories, Inc. · Apr 1996
4C PLUS COULTER CELL CONTROL
K955016 · Coulter Corp. · Jan 1996
QBC CENTRIFUGAL HEMATOLOGY CONTROL
K954137 · R&D Systems, Inc. · Oct 1995
AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II
K952720 · Aalto Scientific, Ltd. · Sep 1995