Broncus Medical, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Broncus Medical, Inc.” (first 2013, latest 2026), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 167 days. Since 2017 the median was 277 days, against 124 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 167 |
| 2014 | 1 | 113 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 94 |
| 2020 | 0 | — |
| 2021 | 1 | 302 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 284 |
| 2025 | 0 | — |
| 2026 | 1 | 112 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Broncus Medical, Inc. took a median 277 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 124 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | 4 | 4 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
Review panels
Most recent Broncus Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260009 | LungPoint Virtual Bronchoscopic Navigation (VBN) Software | LLZ | 2026-04-24 | 112 |
| K232601 | BroncTru Transbronchial Access Tool | EOQ | 2024-05-31 | 277 |
| K232038 | BioStar Single Use Transbronchial Aspiration Needle | EOQ | 2024-04-26 | 291 |
| K200702 | EasyPath RF Introducer Sheath | EOQ | 2021-01-14 | 302 |
| K183240 | Empower RF Catheter | GEI | 2019-02-22 | 94 |
| K133385 | LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWARE | LLZ | 2014-02-26 | 113 |
| K131234 | LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON) | EOQ | 2013-10-15 | 167 |
Recalls
openFDA lists no recalls under a recalling firm named Broncus Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Broncus Medical, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02867371: Evaluation of the Archimedes™ System for Transparenchymal Nodule Access 2 (Completed, started 2016-08)
- NCT02130115: LungPoint ATV for Biopsy in Patients Undergoing Lobectomy (Completed, started 2013-03)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Broncus Technologies, Inc. (11 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Broncus Medical, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Broncus Medical, Inc.” (first 2013, latest 2026), across 3 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Broncus Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Broncus Medical, Inc. is 167 days. Since 2017: 277 days, versus 124 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Broncus Medical, Inc.?
The most frequent FDA product codes under this applicant name are EOQ (Bronchoscope (Flexible Or Rigid), 4); LLZ (System, Image Processing, Radiological, 2); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1).
Next steps
- See all 7 Broncus Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EOQ, Broncus Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.