510(k) Report

FDA applicant

Saffeta, Inc.

Mchenry, IL1 decision1984–19840 recalls

FDA records 1 decision for Saffeta, Inc. (Mchenry, IL) in 1984: 1 510(k) clearance. All are in product code KYP (Snake Bite Suction Kit). 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, general hospital panel, where it files most

How often FDA has decided Saffeta, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Saffeta, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Saffeta, Inc.’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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