Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Broncus Technologies, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
14 daysmedian FDA review time
86 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112051 | LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN | Broncus Technologies, Inc. | 2011-10-12 | 86 | 0 |
| K093423 | LUNGPOINT PROCEDURE PLANNING | Broncus Technologies, Inc. | 2009-11-17 | 14 | 0 |
| K091160 | LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM | Broncus Technologies, Inc. | 2009-05-05 | 14 | 0 |
| K090853 | YIELD TISSUE SAMPLER | Broncus Technologies, Inc. | 2009-04-07 | 8 | 0 |
| K090743 | YIELD MINI DOPPLER SYSTEM | Broncus Technologies, Inc. | 2009-04-03 | 14 | 0 |
| K090095 | LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM | Broncus Technologies, Inc. | 2009-03-13 | 57 | 0 |
| K013111 | EXHALE PROBE | Broncus Technologies, Inc. | 2001-10-01 | 13 | 0 |
| K011267 | EXHALE RF PROBE | Broncus Technologies, Inc. | 2001-05-08 | 12 | 0 |
| K010649 | EXHALE DOPPLER SYSTEM | Broncus Technologies, Inc. | 2001-03-20 | 15 | 0 |
| K993900 | COAGULATION ELECTRODE, MODEL 2000; RADIOFREQUENCY GENERATOR, | Broncus Technologies, Inc. | 2000-01-28 | 73 | 0 |
| K980046 | BRONCHIAL CATHETER SYSTEM | Broncus Technologies, Inc. | 1998-05-01 | 115 | 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