Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Techdevice Corporation — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110241 | ENDOLOGIX GUIDEWIRE | Techdevice Corporation | 2011-02-25 | 29 | 0 |
| K053251 | TECHDEVICE GUIDEWIRE | Techdevice Corporation | 2006-03-08 | 107 | 0 |
| K051137 | TECHDEVICE OCCLUSION BALLOON CATHETER | Techdevice Corporation | 2006-02-24 | 296 | 1 |
| K053028 | TECHDEVICE GUIDEWIRE | Techdevice Corporation | 2006-01-31 | 96 | 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