Biolucent, Inc.: FDA clearances and approvals
Biolucent, Inc. has 6 FDA 510(k) clearances (first 2001, latest 2007), across 4 product codes in 1 review panel. Median 510(k) review time: 58 days.
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 |
|---|---|---|---|
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 3 | 3 |
| IYX | Camera, Scintillation (Gamma) | 1 | 1 |
| IZH | System, X-Ray, Mammographic | 1 | 1 |
| KXK | Source, Brachytherapy, Radionuclide | 1 | 1 |
Review panels
- Radiology (6)
Most recent Biolucent, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K070659 | BIOLUCENT APPLICATOR KIT | JAQ | 2007-04-04 | 26 |
| K062830 | BIOLUCENT APPLICATOR KIT | JAQ | 2006-10-20 | 30 |
| K062141 | MAMMOPAD RADIOLUCENT CUSHION | IYX | 2006-09-13 | 48 |
| K061241 | BIOLUCENT APPLICATOR, MODEL RTA-XX | JAQ | 2006-07-28 | 86 |
| K053595 | CURAY CUSTOM SEED ARRAY | KXK | 2006-02-28 | 67 |
| K003795 | BIOLUCENT MAMMOGRAPHY CUSHION | IZH | 2001-02-14 | 68 |
Recalls
openFDA lists no recalls under a recalling firm named Biolucent, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Biolucent, Inc. have?
Biolucent, Inc. has 6 FDA 510(k) clearances (first 2001, latest 2007), across 4 product codes in 1 review panel.
How long does FDA take to clear Biolucent, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Biolucent, Inc.'s cleared 510(k)s is 58 days.
What devices does Biolucent, Inc. make?
Its most frequent FDA product codes are JAQ (System, Applicator, Radionuclide, Remote-Controlled, 3); IYX (Camera, Scintillation (Gamma), 1); IZH (System, X-Ray, Mammographic, 1).
Has Biolucent, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Biolucent, Inc. Related entities may recall under other names.
Next steps
- See all 6 Biolucent, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JAQ, Biolucent, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.