Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medi USA, LP · 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) |
|---|---|---|---|---|---|
| K221654 | medi pneumatic compression system (pcs)-genius (Model 652) | Medi USA, LP | 2022-07-07 | 30 | 0 |
| K183631 | medi pneumatic compression system (pcs) – brio (Model 651) | Medi USA, LP | 2019-01-25 | 30 | 0 |
| K051324 | MEDI BUTLER | Medi USA, LP | 2005-12-05 | 199 | 0 |
| K941926 | MEDI STRUMPF | Medi USA, LP | 1994-06-15 | 56 | 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