Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
International Trade Group, Inc. · 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) |
|---|---|---|---|---|---|
| K171092 | XiniWave II Model ECS322P | International Trade Group, Inc. | 2017-07-10 | 89 | 0 |
| K160773 | Yarlap II | International Trade Group, Inc. | 2016-05-04 | 44 | 0 |
| K141643 | YARLAP | International Trade Group, Inc. | 2015-04-24 | 309 | 0 |
| K100441 | XINIWAVE, MODEL XW-18 | International Trade Group, Inc. | 2010-07-15 | 148 | 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