Bien-Air Surgery SA: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Bien-Air Surgery SA” (first 2009, latest 2022), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 191 days. Since 2017 the median was 266 days, against 191 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 86 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 266 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 266 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Bien-Air Surgery SA took a median 266 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 191 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 3 | 3 |
| HBC | Motor, Drill, Electric | 2 | 2 |
Review panels
- Ear, Nose and Throat (3)
- Neurology (2)
Most recent Bien-Air Surgery SA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221184 | ORiGO System | ERL | 2022-11-02 | 191 |
| K213697 | ORiGO System | HBC | 2022-10-31 | 342 |
| K173066 | OSSEODUO Shaver and Drill System | HBC | 2018-06-22 | 266 |
| K143492 | OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece | ERL | 2015-03-04 | 86 |
| K083720 | OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K | ERL | 2009-03-20 | 95 |
Recalls
5 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2020-09-11.
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.
- Bien-Air Dental, SA (1 510(k)s)
- Bien-Air SA Switzerland (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bien-Air Surgery SA?
FDA lists 5 510(k) clearances under the applicant name “Bien-Air Surgery SA” (first 2009, latest 2022), across 2 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 Bien-Air Surgery SA?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bien-Air Surgery SA is 191 days. Since 2017: 266 days, versus 191 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Bien-Air Surgery SA?
The most frequent FDA product codes under this applicant name are ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, 3); HBC (Motor, Drill, Electric, 2).
Next steps
- See all 5 Bien-Air Surgery SA clearances with predicates and recalls
- Run predicate analysis for product code ERL, Bien-Air Surgery SA'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.