Cleared Traditional

K912494 - SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER

K912494 is an FDA 510(k) clearance for SYSMEX(TM) R-3000 AUTOMATED RETICULOCYT..., manufactured by Toa Medical Electronics USA, Inc.. The device is a Class 2 Hematology device with product code GKL cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K912494 · Toa Medical Electronics USA, Inc. · Hematology device
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Sep 1991
Decision
97d
Days
Class 2
Risk

K912494 is an FDA 510(k) clearance for the SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Toa Medical Electronics USA, Inc. (Los Alamitos, US). The FDA issued a Cleared decision on September 10, 1991 after a review of 97 days - within the typical 510(k) review window.

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. 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 Toa Medical Electronics USA, Inc. devices

FDA 510(k) Submission Details - K912494

510(k) Number K912494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1991
Decision Date September 10, 1991
Days to Decision 97 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
16d faster than avg
Panel avg: 113d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKL Device Classification - Class 2, Special Controls

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)

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