FDA applicant

Sysmex Corp.

Long Grove, IL18 decisions1979–20011 recall

FDA records 18 decisions for Sysmex Corp. (Long Grove, IL) from 1979 to 2001: 18 510(k) clearances. Most are in product codes GKZ (Counter, Differential Cell) and GKL (Counter, Cell, Automated (Particle Counter)). Its devices cite 13 predicates, 5 of them its own earlier devices. 1 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 Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sysmex Corp. since 2007.

Recalls per year

1in 2012

2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Sysmex Corp.’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”

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

Sysmex America, Inc. 31 Sysmex Corporation of America 3 Sysmex/Toa Medical Electronics, Inc. 1

Sysmex Corp.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Sysmex”