Metro Optics of Austin, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Metro Optics of Austin, Inc.” (first 1996, latest 2024), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 113 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 131 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Metro Optics of Austin, Inc. took a median 131 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | 7 | 7 |
| HQD | Lens, Contact (Other Material) - Daily | 1 | 1 |
Review panels
- Ophthalmic (8)
Most recent Metro Optics of Austin, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233221 | Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) | LPL | 2024-02-06 | 131 |
| K100244 | METRO SOFT | LPL | 2010-10-28 | 274 |
| K080512 | REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT | LPL | 2008-07-23 | 149 |
| K031532 | SATUREEYES II (ACOFILCON A), (ACOFILCON B) & (TETRAFILCON A) SOFT CONTACT LENS FOR DAILY WEAR | LPL | 2003-08-01 | 78 |
| K001620 | METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT FROM LEN | LPL | 2000-06-13 | 19 |
| K990264 | COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENS | HQD | 1999-03-31 | 63 |
| K964902 | CONTACT LENSES METRO-G 3X (HIOXIFILCON B) | LPL | 1997-03-11 | 95 |
| K961606 | METRO FOCAL ASPHERIC (POLYMACON) | LPL | 1996-11-20 | 209 |
Recalls
openFDA lists no recalls under a recalling firm named Metro Optics of Austin, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Metro. Hospital & Health Center (1 510(k)s)
- Metro Medical Equipment, Inc. (1 510(k)s)
- Metro Optics, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Metro Optics of Austin, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Metro Optics of Austin, Inc.” (first 1996, latest 2024), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Metro Optics of Austin, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Metro Optics of Austin, Inc. is 113 days.
Which FDA product codes appear under Metro Optics of Austin, Inc.?
The most frequent FDA product codes under this applicant name are LPL (Lenses, Soft Contact, Daily Wear, 7); HQD (Lens, Contact (Other Material) - Daily, 1).
Next steps
- See all 8 Metro Optics of Austin, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LPL, Metro Optics of Austin, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.