Bloxr Corporation: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Bloxr Corporation” (first 2011, latest 2014), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 64 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 | 1 | 42 |
| 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 |
|---|---|---|---|
| PDK | Cream For X-Ray Attenuation | 2 | 1 |
| KPY | Shield, Protective, Personnel | 1 | 1 |
Review panels
- Radiology (3)
Most recent Bloxr Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133684 | ULTRABLOX | PDK | 2014-01-13 | 42 |
| K110900 | DISPOSABLE THYROID COLLAR | KPY | 2011-06-24 | 85 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN120022 | De Novo | Cream For X-Ray Attenuation | 2013-05-09 |
Recalls
openFDA lists no recalls under a recalling firm named Bloxr Corporation.
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 Bloxr Corporation?
FDA lists 2 510(k) clearances under the applicant name “Bloxr Corporation” (first 2011, latest 2014), plus 1 De Novo decision, 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 Bloxr Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bloxr Corporation is 64 days.
Which FDA product codes appear under Bloxr Corporation?
The most frequent FDA product codes under this applicant name are PDK (Cream For X-Ray Attenuation, 2); KPY (Shield, Protective, Personnel, 1).
Next steps
- See all 2 Bloxr Corporation clearances with predicates and recalls
- Run predicate analysis for product code PDK, Bloxr Corporation'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.