Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Broncus Medical, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
167 daysmedian FDA review time
302 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260009 | LungPoint Virtual Bronchoscopic Navigation (VBN) Software | Broncus Medical, Inc. | 2026-04-24 | 112 | 0 |
| K232601 | BroncTru™ Transbronchial Access Tool | Broncus Medical, Inc. | 2024-05-31 | 277 | 0 |
| K232038 | BioStar Single Use Transbronchial Aspiration Needle | Broncus Medical, Inc. | 2024-04-26 | 291 | 0 |
| K200702 | EasyPath RF Introducer Sheath | Broncus Medical, Inc. | 2021-01-14 | 302 | 0 |
| K183240 | Empower RF Catheter | Broncus Medical, Inc. | 2019-02-22 | 94 | 0 |
| K133385 | LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWARE | Broncus Medical, Inc. | 2014-02-26 | 113 | 0 |
| K131234 | LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOO | Broncus Medical, Inc. | 2013-10-15 | 167 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda