FDA applicant

Koo Americas, Inc.

Alpharetta, GA1 decision2005–20050 recalls

FDA records 1 decision for Koo Americas, Inc. (Alpharetta, GA) in 2005: 1 510(k) clearance. All are in product code BYE (Attachment, Breathing, Positive End Expiratory…). 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 Koo Americas, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Koo Americas, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Koo Americas, Inc.’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

Koo Americas, Inc.

Which product codes does it file in?

What has FDA decided for it lately?