Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MUW · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
84 daysmedian FDA review time
194 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K183200 | iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology | C&E GP Specialist, Inc. | 2019-01-09 | 51 | 0 |
| K160859 | OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) | Contamac, Ltd. | 2016-07-13 | 106 | 0 |
| K010109 | FLUOROPERM 151-OK, PARAGON HDS 100-OK | Paragon Vision Sciences | 2001-02-28 | 47 | 0 |
| K003933 | BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERAT | Polymer Technology | 2001-02-16 | 58 | 0 |
| K000224 | FLUROPERM 60-OK, PARAGON HDS-OK | Paragon Vision Sciences | 2000-04-17 | 84 | 0 |
| K973697 | AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES | Airperm, Inc. | 1998-04-08 | 194 | 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