Cleared Traditional

K954607 - RETICULOCYTE METHOD

K954607 is the FDA 510(k) clearance for RETICULOCYTE METHOD by Bayer Corp.. It is a Class 2 Hematology device (product code GKL) cleared through the Traditional 510(k) pathway after a 331-day FDA review.

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
Combination Product No
PCCP Authorized No
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 52
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K954607.
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K930685 · Heraeus Kulzer, Inc. · Jun 1993
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