Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
3Shape TRIOS 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) |
|---|---|---|---|---|---|
| K260082 | TRIOS Dx (R1) | 3Shape TRIOS A/S | 2026-04-10 | 88 | 0 |
| K242103 | TRIOS Ready Tip | 3Shape TRIOS A/S | 2025-04-04 | 260 | 0 |
| K221249 | L1P-1F (TRIOS 5) | 3Shape TRIOS A/S | 2022-09-16 | 137 | 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