FDA applicant

Advanced Breath Diagnostics

Brentwood1 decision2015–20150 recalls

FDA records 1 decision for Advanced Breath Diagnostics (Brentwood) in 2015: 1 original PMA approval. All are in product code PGE (Gastric Emptying Breath Test). 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, clinical chemistry panel, where it files most

How often FDA has decided Advanced Breath Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Advanced Breath Diagnostics by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Advanced Breath Diagnostics

Which product codes does it file in?

What has FDA decided for it lately?