Broncus Technologies, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Broncus Technologies, Inc.” (first 1998, latest 2011), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 14 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | 5 | 5 |
| LLZ | System, Image Processing, Radiological | 4 | 4 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | 2 |
Review panels
- Radiology (6)
- Ear, Nose and Throat (5)
Most recent Broncus Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K112051 | LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE | LLZ | 2011-10-12 | 86 |
| K093423 | LUNGPOINT PROCEDURE PLANNING | LLZ | 2009-11-17 | 14 |
| K091160 | LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM | LLZ | 2009-05-05 | 14 |
| K090853 | YIELD TISSUE SAMPLER | EOQ | 2009-04-07 | 8 |
| K090743 | YIELD MINI DOPPLER SYSTEM | IYN | 2009-04-03 | 14 |
| K090095 | LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM | LLZ | 2009-03-13 | 57 |
| K013111 | EXHALE PROBE | EOQ | 2001-10-01 | 13 |
| K011267 | EXHALE RF PROBE | EOQ | 2001-05-08 | 12 |
| K010649 | EXHALE DOPPLER SYSTEM | IYN | 2001-03-20 | 15 |
| K993900 | COAGULATION ELECTRODE, MODEL 2000; RADIOFREQUENCY GENERATOR, MODEL 20-115 | EOQ | 2000-01-28 | 73 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Broncus Technologies, 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 Technologies, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00207337: Exhale (R) Stent for Emphysema (Completed, started 2004-07)
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 Medical, Inc. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Broncus Technologies, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Broncus Technologies, Inc.” (first 1998, latest 2011), across 3 product codes in 2 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 Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Broncus Technologies, Inc. is 14 days.
Which FDA product codes appear under Broncus Technologies, Inc.?
The most frequent FDA product codes under this applicant name are EOQ (Bronchoscope (Flexible Or Rigid), 5); LLZ (System, Image Processing, Radiological, 4); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 2).
Next steps
- See all 11 Broncus Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EOQ, Broncus Technologies, 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.