Specialty Ultravision, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Specialty Ultravision, Inc.” (first 1996, latest 2001), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 88 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 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | 10 | 10 |
| HQD | Lens, Contact (Other Material) - Daily | 2 | 2 |
Review panels
- Ophthalmic (12)
Most recent Specialty Ultravision, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011542 | SPECIALTY D-UV (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY D-UV MULTIFOCAL (OCUFLICON D) | LPL | 2001-06-26 | 39 |
| K011089 | SPECIALITY 42 UV (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALITY 42 UV TORIC (HEFILCON A) SOFT C | LPL | 2001-05-23 | 43 |
| K003789 | SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR; SPECIALITY 56 UV TORIC (HEFILCON C) SOFT | LPL | 2001-02-21 | 75 |
| K003526 | SPECIALTY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY 55 UV MULTIFOCAL (METHAFILCON) | LPL | 2001-02-12 | 88 |
| K000376 | SPECIALTY 42 (HEFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR, SPECIALTY T-42 TORIC (HEFILCON A) HYDROPHILIC CONTACT | LPL | 2000-03-21 | 43 |
| K993580 | SPECIALTY 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR | LPL | 2000-02-02 | 103 |
| K992787 | EPICON (CARBOSILFOCON A) RIGID GAS PERMEABLE CONTACT LENS DAILY WEAR | HQD | 2000-02-02 | 167 |
| K984090 | SPECIALITY 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR, SPECIALITY 55 (METHAFILCON A) | LPL | 1999-07-07 | 233 |
| K980197 | ULTRACON/ULTRACON S RIGID GAS PERMEABLE CONTACT LENS FOR DAILY WEAR | HQD | 1998-08-04 | 196 |
| K973192 | FLEXLENS, FLEXLENS TORIC | LPL | 1997-11-20 | 87 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Specialty Ultravision, 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.
- Specialty Surgical Products, Inc. (13 510(k)s)
- Specialty Packaging Producs, Inc. (11 510(k)s)
- Specialty Medical Products Co. (4 510(k)s)
- Specialty Appliance Works, Inc. (3 510(k)s)
- Specialty Medical Industries, Inc. (3 510(k)s)
- Specialty Fibres and Materials, Ltd. (2 510(k)s)
- Specialty Health Products, Inc. (2 510(k)s)
- Specialty Spine Products, LLC (2 510(k)s)
- Specialty Water Technologies, Inc. (2 510(k)s)
- Specialty Dialysis Services (1 510(k)s)
- Specialty Drives Technologies, Inc. (1 510(k)s)
- Specialty Engineering, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Specialty Ultravision, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Specialty Ultravision, Inc.” (first 1996, latest 2001), 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 Specialty Ultravision, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Specialty Ultravision, Inc. is 88 days.
Which FDA product codes appear under Specialty Ultravision, Inc.?
The most frequent FDA product codes under this applicant name are LPL (Lenses, Soft Contact, Daily Wear, 10); HQD (Lens, Contact (Other Material) - Daily, 2).
Next steps
- See all 12 Specialty Ultravision, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LPL, Specialty Ultravision, 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.