Cleared Traditional

RETICULOCYTE METHOD (K954607) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K954607 · Bayer Corp. · Hematology device
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Aug 1996
Decision
331d
Days
Class 2
Risk

K954607 is an FDA 510(k) clearance for the RETICULOCYTE METHOD. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on August 30, 1996 after a review of 331 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5200 - 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. Elevated predicate reliance profile. 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 Bayer Corp. devices

Submission Details

510(k) Number K954607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1995
Decision Date August 30, 1996
Days to Decision 331 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
218d slower than avg
Panel avg: 113d · This submission: 331d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKL Counter, Cell, Automated (particle Counter)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5200
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 - GKL Counter, Cell, Automated (particle Counter)

All 129
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K954607.
QBC HEMACAN HEMATOLOGY SYSTEM
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FACSMATE SAMPLE HANDLING DEVICE
K885132 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1988
RETICCOUNT SOFTWARE
K880636 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1988
CELLECT LABTRAK SOFTWARE
K874320 · Instrumentation Laboratory CO · Jan 1988
FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT
K872166 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1987
CELLECT 8E AUTOMATED BLOOD CELL COUNTERS
K862374 · Instrumentation Laboratory CO · Sep 1986