Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
3Shape Medical A/S · 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) |
|---|---|---|---|---|---|
| K202256 | 3Shape Implant Studio | 3Shape Medical A/S | 2020-09-09 | 30 | 0 |
| K152078 | Implant Studio 2015 | 3Shape Medical A/S | 2015-12-04 | 130 | 0 |
| K141570 | IMPLANT STUDIO | 3Shape Medical A/S | 2014-10-31 | 141 | 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