510(k) Report

FDA applicant

Spegas Industries, Ltd.

91450 Jerusalem, IL5 decisions1993–19970 recalls

FDA records 5 decisions for Spegas Industries, Ltd. (91450 Jerusalem, IL) from 1993 to 1997: 5 510(k) clearances. All are in product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). Its devices cite 1 predicate, 1 of them its own earlier devices. 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, anesthesiology panel, where it files most

How often FDA has decided Spegas Industries, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Spegas Industries, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Spegas Industries, 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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