FDA applicant

Lung Trainers, LLC

Miami, FL1 decision2023–20230 recalls

FDA records 1 decision for Lung Trainers, LLC (Miami, FL) in 2023: 1 510(k) clearance. All are in product code BWF (Spirometer, Therapeutic (Incentive)). 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 Lung Trainers, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Lung Trainers, LLC by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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See the 510(k) Report

Other applicant names beginning “Lung”

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

Lung Assist, Inc. 2 Lung Care, Inc. 1 Lung Technologies, Inc. 1 Lung Bioengineering, Inc. 1

Lung Trainers, LLC

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Lung”