FDA applicant

Kist Intl.

Lewiston, ME1 decision1992–19920 recalls

FDA records 1 decision for Kist Intl. (Lewiston, ME) in 1992: 1 510(k) clearance. All are in product code BYO (Bottle, Blow). 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 Kist Intl.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kist Intl. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Kist Intl.’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) Report

Kist Intl.

Which product codes does it file in?

What has FDA decided for it lately?