Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Frontier Novelty, 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) |
|---|---|---|---|---|---|
| K941059 | FRONTIER NOVELTY DAELIM OPTICAL FRAME | Frontier Novelty, Inc. | 1994-04-12 | 35 | 0 |
| K940782 | ARTSUN OPTICAL FRAME | Frontier Novelty, Inc. | 1994-04-12 | 49 | 0 |
| K935954 | OPTICAL FRAME COLLECTION NO. 2 | Frontier Novelty, Inc. | 1994-02-16 | 65 | 0 |
| K933956 | ALDO'S OPTICAL FRAME COLLECTION | Frontier Novelty, Inc. | 1993-10-18 | 67 | 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