Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Osstell AB — 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) |
|---|---|---|---|---|---|
| K181888 | Osstell Beacon | Osstell AB | 2019-08-22 | 405 | 0 |
| K142358 | Osstell IDx | Osstell AB | 2015-02-19 | 178 | 0 |
| K132401 | MEGA ISQ | Osstell AB | 2014-04-09 | 251 | 0 |
| K082523 | OSSTELL ISQ IMPLANT STABILITY METER | Osstell AB | 2008-09-26 | 24 | 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