Xavant Technology (Pty), Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Xavant Technology (Pty), Ltd.” (first 2007, latest 2022), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 143 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 | 217 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 275 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 389 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Xavant Technology (Pty), Ltd. took a median 332 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 162 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BXN | Stimulator, Nerve, Battery-Powered | 6 | 6 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
Review panels
- Anesthesiology (6)
- Neurology (1)
Most recent Xavant Technology (Pty), Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213049 | STIMPOD NMS450 Nerve Stimulator | BXN | 2022-10-16 | 389 |
| K161091 | STIMPOD NMS460 Nerve Stimulator | GZJ | 2017-01-18 | 275 |
| K140853 | STIMPOD ST2-3010 NERVE STIMULATOR | BXN | 2014-11-06 | 217 |
| K110118 | STIMTRODE SINGLE USE NERVE STIMULATOR | BXN | 2011-02-17 | 30 |
| K102084 | STIMPOD NMS450 NERVE STIMULATOR | BXN | 2010-12-16 | 143 |
| K093591 | STIMPOD MODEL NMS-400 NERVE STIMULATOR | BXN | 2009-12-03 | 14 |
| K072092 | XPOD/XMAP NERVE STIMULATOR | BXN | 2007-11-15 | 108 |
Recalls
openFDA lists no recalls under a recalling firm named Xavant Technology (Pty), Ltd..
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 Xavant Technology (Pty), Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Xavant Technology (Pty), Ltd.” (first 2007, latest 2022), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Xavant Technology (Pty), Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Xavant Technology (Pty), Ltd. is 143 days.
Which FDA product codes appear under Xavant Technology (Pty), Ltd.?
The most frequent FDA product codes under this applicant name are BXN (Stimulator, Nerve, Battery-Powered, 6); GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 1).
Next steps
- See all 7 Xavant Technology (Pty), Ltd. clearances with predicates and recalls
- Run predicate analysis for product code BXN, Xavant Technology (Pty), Ltd.'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.