Cleared Traditional

K914014 - FACSTRAK FLOW CYTOMETER

K914014 is the FDA 510(k) clearance for FACSTRAK FLOW CYTOMETER by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K914014 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Hematology device
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Dec 1991
Decision
86d
Days
Class 2
Risk

K914014 is an FDA 510(k) clearance for the FACSTRAK FLOW CYTOMETER. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on December 4, 1991 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K914014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1991
Decision Date December 04, 1991
Days to Decision 86 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 113d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Hematology devices follow this clearance model.

Regulatory Peers - GKZ Counter, Differential Cell

All 225
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K914014.
SYSMEX HEMATOLOGY SYSTEM ACCESSORIES
K920544 · Toa Medical Electronics USA, Inc. · Apr 1992
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K913192 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1992
SYSMEX NE-1500, MODIFICATION
K914744 · Toa Medical Electronics USA, Inc. · Dec 1991
CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER
K913305 · Unipath , Ltd. · Nov 1991
MONOCLONAL ANTIBODY ANTI-CD19
K901186 · Sigma Chemical Co. · Oct 1991
MONOCLONAL ANTIBODY ANTI-CD2
K901187 · Sigma Chemical Co. · Oct 1991