Baxano, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Baxano, Inc.” (first 2007, latest 2012), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 124 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 | 2 | 208 |
| 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 |
|---|---|---|---|
| HAE | Rongeur, Manual | 6 | 6 |
| ETN | Stimulator, Nerve | 3 | 3 |
| BSO | Catheter, Conduction, Anesthetic | 1 | 1 |
Review panels
- Neurology (6)
- Ear, Nose and Throat (3)
- Anesthesiology (1)
Most recent Baxano, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K113073 | IO-TOME DEVICE | HAE | 2012-07-27 | 284 |
| K113533 | NEURO CHECK DEVICE WITH IO-FLEX WIRE | HAE | 2012-04-11 | 133 |
| K110696 | NEURO CHECK DEVICE WITH IO-FLEX WIRE | ETN | 2011-07-07 | 115 |
| K102594 | IO-FLEX CATHETER | BSO | 2011-01-19 | 132 |
| K100958 | MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES | HAE | 2010-07-23 | 107 |
| K092729 | BAXANO NEURO CHECK DEVICE | ETN | 2009-10-02 | 28 |
| K081742 | BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25 | ETN | 2008-09-17 | 90 |
| K080494 | BAXANO ULTRA LOW PROFILE RONGEUR | HAE | 2008-03-04 | 11 |
| K063231 | MICROBLADE SHAVER AND ACCESSORIES | HAE | 2007-04-16 | 173 |
| K062711 | ULTRA LOW PROFILE RONGEUR | HAE | 2007-03-07 | 177 |
Recalls
openFDA lists no recalls under a recalling firm named Baxano, 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.
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.
- Baxano Surgical, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Baxano, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Baxano, Inc.” (first 2007, latest 2012), 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 Baxano, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Baxano, Inc. is 124 days.
Which FDA product codes appear under Baxano, Inc.?
The most frequent FDA product codes under this applicant name are HAE (Rongeur, Manual, 6); ETN (Stimulator, Nerve, 3); BSO (Catheter, Conduction, Anesthetic, 1).
Next steps
- See all 10 Baxano, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HAE, Baxano, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.