Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QVJ · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233760 | Mjolnir Pro. (Multi–electrode plasma) | Shenzhen Leaflife Technology Co., Ltd. | 2024-02-20 | 88 | 0 |
| K220493 | Plaxpot Multi Plasma | Gcs Co. Limited | 2023-10-27 | 612 | 0 |
| K213247 | JETT PLASMA Medical II | Compex, Spol, S.R.O. | 2023-03-14 | 530 | 0 |
| K223440 | Plasma Pen (Plasma MD); Plasma Pen (Plasma +) | Plasma Concepts | 2023-03-02 | 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