Designs For Vision, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Designs For Vision, Inc.” (first 1980, latest 2005), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 27 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 |
|---|---|---|---|
| EBZ | Activator, Ultraviolet, For Polymerization | 1 | 1 |
| FST | Light, Surgical, Fiberoptic | 1 | 1 |
| FXF | Speculum, Illuminated | 1 | 1 |
| GCT | Light Source, Endoscope, Xenon Arc | 1 | 1 |
| GDB | Endoscope, Fiber Optic | 1 | 1 |
Review panels
Most recent Designs For Vision, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K051786 | MELIDE FIBEROPTIC LIGHT | FST | 2005-08-15 | 45 |
| K043530 | DVI CURING LIGHT | EBZ | 2005-01-25 | 35 |
| K032283 | DESIGNS FOR VISION FIBEROPTIC LIGHT | GDB | 2003-08-20 | 27 |
| K013880 | DAYLITE XENON LIGHT SOURCES | GCT | 2001-12-07 | 14 |
| K801058 | ILLUMINATED SPECULUM | FXF | 1980-05-28 | 22 |
Recalls
openFDA lists no recalls under a recalling firm named Designs For Vision, 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.
- Designs IN Medicine (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Designs For Vision, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Designs For Vision, Inc.” (first 1980, latest 2005), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Designs For Vision, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Designs For Vision, Inc. is 27 days.
Which FDA product codes appear under Designs For Vision, Inc.?
The most frequent FDA product codes under this applicant name are EBZ (Activator, Ultraviolet, For Polymerization, 1); FST (Light, Surgical, Fiberoptic, 1); FXF (Speculum, Illuminated, 1).
Next steps
- See all 5 Designs For Vision, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBZ, Designs For Vision, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.