Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Xavant Technology (Pty), Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
143 daysmedian FDA review time
389 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213049 | STIMPOD NMS450 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2022-10-16 | 389 | 0 |
| K161091 | STIMPOD NMS460 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2017-01-18 | 275 | 0 |
| K140853 | STIMPOD ST2-3010 NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | 2014-11-06 | 217 | 0 |
| K110118 | STIMTRODE SINGLE USE NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | 2011-02-17 | 30 | 0 |
| K102084 | STIMPOD NMS450 NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | 2010-12-16 | 143 | 0 |
| K093591 | STIMPOD MODEL NMS-400 NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | 2009-12-03 | 14 | 0 |
| K072092 | XPOD/XMAP NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | 2007-11-15 | 108 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda