Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Exocad GmbH · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213302 | exoplan | Exocad GmbH | 2022-05-03 | 211 | 1 |
| K193352 | AbutmentCAD | Exocad GmbH | 2021-07-21 | 595 | 0 |
| K183458 | exoplan 2.3 | Exocad GmbH | 2019-08-06 | 236 | 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