Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Hans Biomed Corporation · 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) |
|---|---|---|---|---|---|
| K220549 | MINT Product Family (Including MINT, MINT Lift, and MINT-I S | Hans Biomed Corporation | 2023-03-07 | 375 | 0 |
| K192423 | MINT Product Family | Hans Biomed Corporation | 2020-09-09 | 371 | 0 |
| K171568 | SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty | Hans Biomed Corporation | 2018-02-22 | 268 | 0 |
| K130191 | MINT | Hans Biomed Corporation | 2013-06-12 | 138 | 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