FDA applicant

Broncus Medical, Inc.

San Jose, CA7 decisions2013–20260 recalls

FDA records 7 decisions for Broncus Medical, Inc. (San Jose, CA) from 2013 to 2026: 7 510(k) clearances. Most are in product codes EOQ (Bronchoscope (Flexible Or Rigid)) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 277 days from receipt to decision, against 130 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 3 of them its own earlier devices. 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

2in 2024

2013high 2 (2024) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Broncus Medical, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Broncus Medical, 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 “Broncus”

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

Broncus Technologies, Inc. 11

Broncus Medical, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

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?

Other applicant names beginning “Broncus”