FDA applicant
Sysmex America, Inc.
FDA records 31 decisions for Sysmex America, Inc. (Mundelein, IL) from 2003 to 2026: 31 510(k) clearances. Most are in product codes GKZ (Counter, Differential Cell) and LKM (Counter, Urine Particle). Since 2016 its 510(k)s took a median of 191 days from receipt to decision, against 224 for FDA’s reviews in the same codes and years. Its devices cite 24 predicates, 19 of them its own earlier devices. 5 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Sysmex America, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
1in 2017
Class I Class II/III not classified
Planning a device like Sysmex America, 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) ReportOther applicant names beginning “Sysmex”
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