FDA applicant

Sysmex/Toa Medical Electronics, Inc.

Mchenry, IL1 decision1982–19820 recalls

FDA records 1 decision for Sysmex/Toa Medical Electronics, Inc. (Mchenry, IL) in 1982: 1 510(k) clearance. All are in product code GKL (Counter, Cell, Automated (Particle Counter)). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, hematology panel, where it files most

How often FDA has decided Sysmex/Toa Medical Electronics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sysmex/Toa Medical Electronics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sysmex/Toa Medical Electronics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sysmex/Toa Medical Electronics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Sysmex/Toa”

FDA records each applicant name separately; these may or may not be the same firm.

Sysmex America, Inc. 31 Sysmex Corp. 18 Sysmex Corporation of America 3

Sysmex/Toa Medical Electronics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Sysmex/Toa”