Xoft, Inc.: FDA clearances and approvals
Xoft, Inc. has 6 FDA 510(k) clearances (first 2005, latest 2009), across 2 product codes in 1 review panel. Median 510(k) review time: 143 days. openFDA lists 1 product recall by a recalling firm named Xoft, Inc. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
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 |
|---|---|---|---|
| JAD | System, Therapeutic, X-Ray | 5 | 5 |
| IXI | Block, Beam-Shaping, Radiation Therapy | 1 | 1 |
Review panels
- Radiology (6)
Most recent Xoft, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090914 | AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E | JAD | 2009-07-16 | 106 |
| K090417 | AXXENT FLEXISHIELD MINI | IXI | 2009-06-23 | 125 |
| K083734 | AXXENT SURFACE APPLICATOR, MODEL 710257 | JAD | 2009-02-11 | 57 |
| K072616 | AXXENT VAGINAL APPLICATOR | JAD | 2008-05-09 | 235 |
| K072683 | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM | JAD | 2008-02-29 | 161 |
| K050843 | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM | JAD | 2005-12-22 | 265 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2011-02-03.
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.
Device clinical trials
Xoft, Inc. is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05257486: Post-market Multi-Center RETRO-Prospective Study to Assess Long-term Clinical Outcomes NMSC Patients Treated With eBx (Completed, started 2022-03-09)
- NCT01851772: Feasibility Study of the Xoft® Axxent® Electronic Brachytherapy System for the Treatment of Cervical Cancer (Completed, started 2013-11)
Frequently asked questions
How many FDA 510(k) clearances does Xoft, Inc. have?
Xoft, Inc. has 6 FDA 510(k) clearances (first 2005, latest 2009), across 2 product codes in 1 review panel.
How long does FDA take to clear Xoft, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Xoft, Inc.'s cleared 510(k)s is 143 days.
What devices does Xoft, Inc. make?
Its most frequent FDA product codes are JAD (System, Therapeutic, X-Ray, 5); IXI (Block, Beam-Shaping, Radiation Therapy, 1).
Has Xoft, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Xoft, Inc; the most recent began 2011-02-03. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 6 Xoft, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JAD, Xoft, 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.