Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
The Limited Stores, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
66 daysmedian FDA review time
84 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K941875 | SUNGLASSES | The Limited Stores, Inc. | 1994-06-03 | 46 | 0 |
| K910125 | SUNGLASSES/NON-PRESCRIPTION (LA GIARDINIERA) | The Limited Stores, Inc. | 1991-03-14 | 66 | 0 |
| K905864 | SUNGLASSES (NON-PRESCRIPTION) | The Limited Stores, Inc. | 1991-03-14 | 84 | 0 |
| K910126 | SUNGLASSES, NON-PRESCRIPTION (ITALO CREMONA) | The Limited Stores, Inc. | 1991-03-14 | 66 | 0 |
| K910127 | SUNGLASSES, NON-PRESCRIPTION (POLINELLI) | The Limited Stores, Inc. | 1991-03-14 | 66 | 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