Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sk Med · 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) |
|---|---|---|---|---|---|
| K031860 | SK MED ME202 MONITORING MIXER | Sk Med | 2004-01-21 | 219 | 0 |
| K031707 | SK MED M201 PLUS MIXER | Sk Med | 2003-08-01 | 60 | 0 |
| K022864 | SK MED M201 MIXER | Sk Med | 2003-04-11 | 226 | 0 |
| K974372 | AIR OXYGE MIXER | Sk Med | 1998-02-05 | 77 | 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