Proxima Therapeutics, Inc.: FDA clearances and approvals
Proxima Therapeutics, Inc. has 5 FDA 510(k) clearances (first 2001, latest 2004), across 2 product codes in 1 review panel. Median 510(k) review time: 194 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 | 4 | 4 |
| KXK | Source, Brachytherapy, Radionuclide | 1 | 1 |
Review panels
- Radiology (5)
Most recent Proxima Therapeutics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041929 | MAMMOSITE II RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY | JAQ | 2004-08-26 | 38 |
| K032067 | MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY | JAQ | 2004-02-10 | 222 |
| K030558 | MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY | JAQ | 2003-05-21 | 89 |
| K011690 | MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY | JAQ | 2002-05-06 | 340 |
| K003206 | GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005 | KXK | 2001-04-25 | 194 |
Recalls
openFDA lists no recalls under a recalling firm named Proxima Therapeutics, 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 Proxima Therapeutics, Inc. have?
Proxima Therapeutics, Inc. has 5 FDA 510(k) clearances (first 2001, latest 2004), across 2 product codes in 1 review panel.
How long does FDA take to clear Proxima Therapeutics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Proxima Therapeutics, Inc.'s cleared 510(k)s is 194 days.
What devices does Proxima Therapeutics, Inc. make?
Its most frequent FDA product codes are JAQ (System, Applicator, Radionuclide, Remote-Controlled, 4); KXK (Source, Brachytherapy, Radionuclide, 1).
Has Proxima Therapeutics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Proxima Therapeutics, Inc. Related entities may recall under other names.
Next steps
- See all 5 Proxima Therapeutics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JAQ, Proxima Therapeutics, 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.