Cleared Special

K010064 - 4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190

K010064 is an FDA 510(k) clearance for 4C-ES CELL, manufactured by Beckman Coulter, Inc.. The device is a Class 2 Hematology device with product code JPK cleared through the Special 510(k) pathway after a 30-day FDA review.

K010064 · Beckman Coulter, Inc. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
30d
Days
Class 2
Risk

K010064 is an FDA 510(k) clearance for the 4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Miami, US). The FDA issued a Cleared decision on February 7, 2001 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K010064

510(k) Number K010064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2001
Decision Date February 07, 2001
Days to Decision 30 days
Submission Type Special
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
83d faster than avg
Panel avg: 113d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

JPK Device Classification - Class 2, Special Controls

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 185
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K010064.
ADVIA RETIC PLUS
K010461 · R&D Systems, Inc. · Apr 2001
SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL
K010598 · Quantimetrix Corp. · Mar 2001
CBC-SF
K010409 · R&D Systems, Inc. · Mar 2001
5C-ES CELL CONTROL, MODELS 7547191, 7547192
K010066 · Beckman Coulter, Inc. · Feb 2001
CBC-4K HEMATOLOGY CONTROL
K003874 · R&D Systems, Inc. · Jan 2001
PENTRA 5D
K003534 · R&D Systems, Inc. · Dec 2000
K010064 · 4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190
Download PDF FDA Summary Beckman Coulter, Inc.