Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Moyco Industries, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
33 daysmedian FDA review time
164 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K932511 | SILICONE MIRROR | Moyco Industries, Inc. | 1993-11-05 | 164 | 0 |
| K833558 | X-RAY SHIELD | Moyco Industries, Inc. | 1984-01-13 | 92 | 0 |
| K821444 | COLORED WEDGE USED TO SEPARATE TEETH | Moyco Industries, Inc. | 1982-06-14 | 31 | 0 |
| K821629 | FIXIDENT | Moyco Industries, Inc. | 1982-06-14 | 12 | 0 |
| K810839 | SPOTAR | Moyco Industries, Inc. | 1981-04-29 | 33 | 0 |
| K810912 | ALLOY COMPOSITE POLISH | Moyco Industries, Inc. | 1981-04-23 | 17 | 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