Cleared Traditional

K933486 - FASCOUNT SYSTME

K933486 is an FDA 510(k) clearance for FASCOUNT SYSTME, manufactured by Becton Dickinson Immunocytometry Systems. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 417-day FDA review.

K933486 · Becton Dickinson Immunocytometry Systems · Hematology device
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Sep 1994
Decision
417d
Days
Class 2
Risk

K933486 is an FDA 510(k) clearance for the FASCOUNT SYSTME. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Becton Dickinson Immunocytometry Systems (San Jose, US). The FDA issued a Cleared decision on September 9, 1994 after a review of 417 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Becton Dickinson Immunocytometry Systems devices

FDA 510(k) Submission Details - K933486

510(k) Number K933486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1993
Decision Date September 09, 1994
Days to Decision 417 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
304d slower than avg
Panel avg: 113d · This submission: 417d
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 Hematology devices follow this clearance model.

Regulatory Peers - GKZ Counter, Differential Cell

All 295
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K933486.
MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25
K944253 · Dako Corp. · Nov 1994
MONOCLONAL MOUSE ANTI-HUMAN T-CELL
K942797 · Dako Corp. · Nov 1994
AUTOCOMP(TM) SOFTWARE AND CALIBRITE(TM) BEADS
K925274 · Becton Dickinson Immunocytometry Systems · Sep 1994
SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER
K936023 · Toa Medical Electronics USA, Inc. · May 1994
FACSORT FLOW CYTOMETER
K923790 · Becton Dickinson Immunocytometry Systems · Sep 1993
COULTER MH015 (DIFFERENTIAL CELL COUNTER)
K930913 · Coulter Corp. · Aug 1993