Blublocker Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Blublocker Corp.” (first 1990, latest 1996), across 1 product code in 1 review panel. Median 510(k) review time under this name: 49 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 |
|---|---|---|---|
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | 7 | 7 |
Review panels
- Ophthalmic (7)
Most recent Blublocker Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954659 | MOONSHADES SUNGLASSES | HQY | 1996-01-11 | 93 |
| K950807 | SUNBLOCKER SUNGLASSES | HQY | 1995-05-24 | 91 |
| K901160 | NUBALOO(R) SUNGLASSES | HQY | 1990-06-14 | 93 |
| K901161 | SOLAR SHADES(TM) SUNGLASSES | HQY | 1990-05-01 | 49 |
| K900383 | BULLET SUNGLASSES | HQY | 1990-02-13 | 19 |
| K900382 | BLUBLOCKER SUNGLASSES | HQY | 1990-02-13 | 19 |
| K900381 | COLORVISION SUNGLASSES | HQY | 1990-02-13 | 19 |
Recalls
openFDA lists no recalls under a recalling firm named Blublocker Corp..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Blublocker Corp.?
FDA lists 7 510(k) clearances under the applicant name “Blublocker Corp.” (first 1990, latest 1996), across 1 product code 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 Blublocker Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Blublocker Corp. is 49 days.
Which FDA product codes appear under Blublocker Corp.?
The most frequent FDA product codes under this applicant name are HQY (Sunglasses (Non-Prescription Including Photosensitive), 7).
Next steps
- See all 7 Blublocker Corp. clearances with predicates and recalls
- Run predicate analysis for product code HQY, Blublocker Corp.'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.