Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nortrade Medical, 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) |
|---|---|---|---|---|---|
| K990179 | BURNFREE 1/8 OZ. STERILE PAIN RELIEVING GEL, MODEL SD | Nortrade Medical, Inc. | 1999-08-13 | 205 | 1 |
| K990178 | BURNFREE PAIN RELIEVING GEL, MODEL 4B | Nortrade Medical, Inc. | 1999-08-13 | 205 | 0 |
| K990180 | BURNFREE (4X4, 8X8, 16X24) STERILE BURN & WOUND DRESSING | Nortrade Medical, Inc. | 1999-08-13 | 205 | 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