Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Bovie Medical Corporation Dba Apyx Medical Corporation · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192867 | Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3) | Bovie Medical Corporation Dba Apyx Medical Corporation | 2019-10-31 | 24 | 0 |
| K191542 | Apyx Plasma/RF Handpiece | Bovie Medical Corporation Dba Apyx Medical Corporation | 2019-10-11 | 122 | 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