FDA applicant
Sight Diagnostics, Ltd.
FDA records 1 decision for Sight Diagnostics, Ltd. (Tel Aviv, IL) in 2019: 1 510(k) clearance. All are in product code GKZ (Counter, Differential Cell). Its devices cite 1 predicate, 0 of them its own earlier devices. 4 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Sight Diagnostics, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like Sight Diagnostics, Ltd.’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 “Sight”
FDA records each applicant name separately; these may or may not be the same firm.