Cleared Traditional

K955016 - 4C PLUS COULTER CELL CONTROL

K955016 is the FDA 510(k) clearance for 4C PLUS COULTER CELL CONTROL by Coulter Corp.. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K955016 · Coulter Corp. · Hematology device
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Jan 1996
Decision
89d
Days
Class 2
Risk

K955016 is an FDA 510(k) clearance for the 4C PLUS COULTER CELL 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 January 30, 1996 after a review of 89 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 K955016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1995
Decision Date January 30, 1996
Days to Decision 89 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 113d · This submission: 89d
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 K955016.
R&D RETIC-PG HEMATOLOGY CONTROL
K961673 · R&D Systems, Inc. · Jul 1996
CALIBRATION VERIFICATION ASSESSMENT (CVA)
K960557 · Streck Laboratories, Inc. · Apr 1996
COULTER LINEARITY CONTROL
K955334 · Coulter Corp. · Feb 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
SF-CHECK
K952245 · Streck Laboratories, Inc. · Sep 1995