Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Midwest Reprocessing Center, LLC — 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) |
|---|---|---|---|---|---|
| K111007 | MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWES | Midwest Reprocessing Center, LLC | 2011-06-08 | 58 | 0 |
| K101280 | MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PR | Midwest Reprocessing Center, LLC | 2010-10-07 | 154 | 0 |
| K101702 | MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOO | Midwest Reprocessing Center, LLC | 2010-08-27 | 71 | 0 |
| K101330 | MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ | Midwest Reprocessing Center, LLC | 2010-08-27 | 107 | 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