Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Masel Industries, 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) |
|---|---|---|---|---|---|
| K920645 | ORTHODONTIC ELASTICS BANDS | Masel Industries, Inc. | 1992-07-28 | 167 | 0 |
| K911231 | ORTHODONTIC WIRE | Masel Industries, Inc. | 1991-10-08 | 202 | 0 |
| K903498 | RETAINER, SCREW EXPANSION ORTHODONTIC | Masel Industries, Inc. | 1991-03-12 | 221 | 0 |
| K902809 | BRACKET, METAL, ORTHODOTNIC | Masel Industries, Inc. | 1990-12-07 | 163 | 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