Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Canadian Pioneer Medical Technology Corporation · 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) |
|---|---|---|---|---|---|
| K211722 | Laser treatment system , models Nyx plus, Grace plus, Nemesi | Canadian Pioneer Medical Technology Corporation | 2022-02-25 | 266 | 0 |
| K212793 | Laser Treatment System, Model: Hera, Armo | Canadian Pioneer Medical Technology Corporation | 2021-10-25 | 54 | 0 |
| K210033 | Laser Treatment System, Model: NYX and Grace | Canadian Pioneer Medical Technology Corporation | 2021-02-26 | 52 | 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