510(k) Report

FDA applicant

Blease Medical Equipment, Ltd.

Appollo Beach, FL5 decisions1999–20044 recalls

FDA records 5 decisions for Blease Medical Equipment, Ltd. (Appollo Beach, FL) from 1999 to 2004: 5 510(k) clearances. Most are in product codes BSZ (Gas-Machine, Anesthesia) and CBK (Ventilator, Continuous, Facility Use). Its devices cite 2 predicates, 2 of them its own earlier devices. 4 recalls are linked to its devices, 2 Class I.

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 Medical Equipment, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Blease Medical Equipment, Ltd. since 2007.

Recalls per year

2in 2013

2012: 12013: 2, 2 Class I
2007high 2 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Blease Medical Equipment, Ltd.’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.