Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tanses Technologies, Inc. — 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) |
|---|---|---|---|---|---|
| K180585 | Collagentex Rx-6 | Tanses Technologies, Inc. | 2018-05-11 | 67 | 0 |
| K162022 | Collagentex Rx-1 | Tanses Technologies, Inc. | 2016-12-22 | 154 | 0 |
| K152412 | T-32;T-40;T-44;T-52;T-72;TT-50 | Tanses Technologies, Inc. | 2016-04-29 | 247 | 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