Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Norton Texas Medical Products · 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) |
|---|---|---|---|---|---|
| K843983 | MYOCARDIAL INSULATOR | Norton Texas Medical Products | 1984-12-27 | 77 | 0 |
| K842194 | PRESSURE MONITOR | Norton Texas Medical Products | 1984-08-27 | 84 | 0 |
| K842992 | GRASSHOPPER - RETRACTOR | Norton Texas Medical Products | 1984-08-17 | 18 | 0 |
| K832517 | CUSTOM KWIK SET AND/OR PAK | Norton Texas Medical Products | 1983-10-14 | 78 | 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