FDA applicant

Blease USA, Inc.

Appollo Beach, FL2 decisions1995–20053 recalls

FDA records 2 decisions for Blease USA, Inc. (Appollo Beach, FL) from 1995 to 2005: 2 510(k) clearances. Most are in product codes BSZ (Gas-Machine, Anesthesia) and CAD (Vaporizer, Anesthesia, Non-Heated). Its devices cite 1 predicate, 0 of them its own earlier devices. 3 recalls are 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 Blease USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Blease USA, Inc. since 2007.

Recalls per year

2in 2010

2007high 2 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Blease USA, 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

Other applicant names beginning “Blease”

FDA records each applicant name separately; these may or may not be the same firm.

Blease Medical Equipment, Ltd. 5

Blease USA, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Blease”