Cleared Traditional

K904795 - FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM

K904795 is the FDA 510(k) clearance for FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 1 Hematology device (product code GKH) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K904795 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1990
Decision
73d
Days
Class 1
Risk

K904795 is an FDA 510(k) clearance for the FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM. Classified as Apparatus, Automated Blood Cell Diluting (product code GKH), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on December 31, 1990 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5240 - 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 K904795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1990
Decision Date December 31, 1990
Days to Decision 73 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 113d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GKH Apparatus, Automated Blood Cell Diluting
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.5240
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GKH Apparatus, Automated Blood Cell Diluting

All 7
Devices cleared under the same product code (GKH) and FDA review panel - the closest regulatory comparables to K904795.
COULTER CELLPREP
K021150 · Beckman Coulter, Inc. · Jun 2002
COULTER MULTI Q PREP
K935953 · Coulter Corp. · Mar 1994
COULTER MULTI-Q-PREP
K923530 · Coulter Electronics, Inc. · Oct 1992
SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM
K882767 · Toa Medical Electronics USA, Inc. · Jul 1988
AD150, AUTOMATED HEMATOLOGY DILUTOR
K852373 · Abbott Diagnostics · Jul 1985
HYCEL DILUTOR, VARIOUS MODELS/MULTI
K842747 · R&D Systems, Inc. · Oct 1984