Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aspect Vision Care, Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
61 daysmedian FDA review time
146 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K982997 | FREQUENCY 55 UV (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR | Aspect Vision Care, Ltd. | 1999-01-20 | 146 | 0 |
| K980634 | FREQUENCY UV (ETAFILCON A) HYDROPHILIC CONTACT LENS FOR DAIL | Aspect Vision Care, Ltd. | 1998-04-22 | 62 | 0 |
| K973063 | FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DA | Aspect Vision Care, Ltd. | 1997-08-26 | 8 | 1 |
| K971164 | FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS | Aspect Vision Care, Ltd. | 1997-05-21 | 51 | 0 |
| K971049 | FREQUENCY 38 (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY | Aspect Vision Care, Ltd. | 1997-05-21 | 61 | 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