Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Metro Optics of Austin, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
131 daysmedian FDA review time
274 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233221 | Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens ( | Metro Optics of Austin, Inc. | 2024-02-06 | 131 | 0 |
| K100244 | METRO SOFT | Metro Optics of Austin, Inc. | 2010-10-28 | 274 | 0 |
| K080512 | REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIO | Metro Optics of Austin, Inc. | 2008-07-23 | 149 | 0 |
| K031532 | SATUREEYES II (ACOFILCON A), (ACOFILCON B) & (TETRAFILCON A) | Metro Optics of Austin, Inc. | 2003-08-01 | 78 | 0 |
| K001620 | METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CO | Metro Optics of Austin, Inc. | 2000-06-13 | 19 | 0 |
| K990264 | COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP) | Metro Optics of Austin, Inc. | 1999-03-31 | 63 | 0 |
| K964902 | CONTACT LENSES METRO-G 3X (HIOXIFILCON B) | Metro Optics of Austin, Inc. | 1997-03-11 | 95 | 0 |
| K961606 | METRO FOCAL ASPHERIC (POLYMACON) | Metro Optics of Austin, Inc. | 1996-11-20 | 209 | 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