FDA applicant

Lung Bioengineering, Inc.

Silver Spring1 decision2026–20260 recalls

FDA records 1 decision for Lung Bioengineering, Inc. (Silver Spring) in 2026: 1 original PMA approval. All are in product code PHO (Normothermic Preservation System For…). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Lung Bioengineering, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

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

Planning a device like Lung Bioengineering, 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 “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 Trainers, LLC 1 Lung Technologies, Inc. 1

Lung Bioengineering, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Lung”