510(k) Report

FDA applicant

Aoti, Ltd.

Galway, IE1 decision2008–20080 recalls

FDA records 1 decision for Aoti, Ltd. (Galway, IE) in 2008: 1 510(k) clearance. All are in product code KPJ (Chamber, Oxygen, Topical, Extremity). Its devices cite 3 predicates, 0 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Aoti, Ltd. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Aoti, 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?

  • KPJChamber, Oxygen, Topical, Extremity1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K080966Hyper-Box Topical Wound Oxygen SystemAoti, Ltd. · 20081cites it

What has FDA decided for it lately?

  • K080966Hyper-Box Topical Wound Oxygen SystemAoti, Ltd. · 2008

The one decision as Aoti, Ltd. →