510(k) Report

FDA applicant

S.D. Sight Diagnostics, Ltd.

Tel Aviv, IL1 decision2022–20221 recall

FDA records 1 decision for S.D. Sight Diagnostics, Ltd. (Tel Aviv, IL) in 2022: 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. 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 S.D. Sight Diagnostics, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

1in 2024

2024: 1
2022high 1 (2024) · low 0 (2022)2026

Class I Class II/III not classified

FIG. 1 — S.D. Sight Diagnostics, Ltd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like S.D. 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.

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Which product codes does it file in?

  • GKZCounter, Differential Cell1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K211840Sight OLOS.D. Sight Diagnostics, Ltd. · 20221 recall

The one decision as S.D. Sight Diagnostics, Ltd. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K190898Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample…May 13, 2024Class II