Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shenzhen Xft Medical Limited · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211094 | Nerve and Muscle Stimulator | Shenzhen Xft Medical Limited | 2021-07-08 | 87 | 0 |
| K193276 | Nerve and Muscle Stimulator | Shenzhen Xft Medical Limited | 2020-09-23 | 302 | 0 |
| K193275 | Nerve and Muscle Stimulator | Shenzhen Xft Medical Limited | 2020-04-11 | 137 | 0 |
| K162718 | Foot Drop System (Model XFT-2001D) | Shenzhen Xft Medical Limited | 2017-11-30 | 427 | 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