Cleared Traditional

K041074 - BD FACSCANTO WITH BD FACSANTO SOFTWARE

K041074 is an FDA 510(k) clearance for BD FACSCANTO WITH BD FACSANTO SOFTWARE, manufactured by Bd Biosciences. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K041074 · Bd Biosciences · Hematology device
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Sep 2004
Decision
144d
Days
Class 2
Risk

K041074 is an FDA 510(k) clearance for the BD FACSCANTO WITH BD FACSANTO SOFTWARE. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Bd Biosciences (San Jose, US). The FDA issued a Cleared decision on September 17, 2004 after a review of 144 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bd Biosciences devices

FDA 510(k) Submission Details - K041074

510(k) Number K041074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2004
Decision Date September 17, 2004
Days to Decision 144 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
31d slower than avg
Panel avg: 113d · This submission: 144d
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 K041074.
FLOWCARE SYSTEM
K041882 · Pointcare Technologies, Inc. · Nov 2004
MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER
K042724 · Beckman Coulter, Inc. · Oct 2004
COULTER A T 5DIFF CAP PIERCE (CP)
K042173 · Beckman Coulter, Inc. · Oct 2004
BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
K042251 · Bayer Healthcare, LLC · Sep 2004
BD FACS 7-COLOR SETUP BEADS
K040026 · Becton Dickinson Immunocytometry Systems · Sep 2004
BD FACSCANTO SYSTEM
K040725 · Becton Dickinson Immunocytometry Systems · Sep 2004