Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bien-Air Surgery SA · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
191 daysmedian FDA review time
342 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221184 | ORiGO System | Bien-Air Surgery SA | 2022-11-02 | 191 | 0 |
| K213697 | ORiGO System | Bien-Air Surgery SA | 2022-10-31 | 342 | 0 |
| K173066 | OSSEODUO Shaver and Drill System | Bien-Air Surgery SA | 2018-06-22 | 266 | 0 |
| K143492 | OSSEOSTAP Microdrill System (control unit and handpiece), OS | Bien-Air Surgery SA | 2015-03-04 | 86 | 0 |
| K083720 | OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K | Bien-Air Surgery SA | 2009-03-20 | 95 | 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