Cleared Traditional

K182886 - Cytomics FC 500 Series (MPL or MCL) Flo...

K182886 is an FDA 510(k) clearance for Cytomics FC 500 Series (MPL or MCL) Flo..., manufactured by Beckman Coulter. The device is a Class 2 Immunology device with product code GKZ cleared through the Traditional 510(k) pathway after a 326-day FDA review.

K182886 · Beckman Coulter · Immunology device
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Sep 2019
Decision
326d
Days
Class 2
Risk

K182886 is an FDA 510(k) clearance for the Cytomics FC 500 Series (MPL or MCL) Flow Cytometer. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Beckman Coulter (Miami, US). The FDA issued a Cleared decision on September 6, 2019 after a review of 326 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 864.5220 - the FDA immunology 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Beckman Coulter devices

FDA 510(k) Submission Details - K182886

510(k) Number K182886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2018
Decision Date September 06, 2019
Days to Decision 326 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
222d slower than avg
Panel avg: 104d · This submission: 326d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKZ Device Classification - Class 2, Special Controls

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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 Immunology devices follow this clearance model.

Regulatory Peers - GKZ Counter, Differential Cell

All 226
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