Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Od-Os GmbH — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251772 | Navilas Laser System 577sl (156691) | Od-Os GmbH | 2025-10-29 | 141 | 0 |
| K162191 | NAVILAS Laser System | Od-Os GmbH | 2016-11-22 | 110 | 0 |
| K141851 | NAVILAS LASER SYSTEM | Od-Os GmbH | 2015-01-02 | 177 | 0 |
| K091064 | NAVILAS LASER SYSTEM | Od-Os GmbH | 2009-10-27 | 196 | 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