Cleared Traditional

K910849 - SYSMEX F-810

K910849 is the FDA 510(k) clearance for SYSMEX F-810 by Toa Medical Electronics USA, Inc.. It is a Class 2 Hematology device (product code GKL) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K910849 · Toa Medical Electronics USA, Inc. · Hematology device
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Jul 1991
Decision
149d
Days
Class 2
Risk

K910849 is an FDA 510(k) clearance for the SYSMEX F-810. 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 July 26, 1991 after a review of 149 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

Submission Details

510(k) Number K910849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1991
Decision Date July 26, 1991
Days to Decision 149 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 113d · This submission: 149d
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)

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