FDA applicant

Almost U., Inc.

Peekskill, NY1 decision1993–19930 recalls

FDA records 1 decision for Almost U., Inc. (Peekskill, NY) in 1993: 1 510(k) clearance. All are in product code KCZ (Prosthesis, Breast, External, Used With Adhesive). 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 Almost U., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Almost U., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Almost U., 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

Almost U., Inc.

Which product codes does it file in?

What has FDA decided for it lately?