Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mada Medical Products, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
98 daysmedian FDA review time
288 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K003862 | MADA WHEELCHAIRS | Mada Medical Products, Inc. | 2001-01-12 | 30 | 0 |
| K002943 | WHEELCHAIR, MECHANICAL SERIES MODEL 3100 | Mada Medical Products, Inc. | 2000-10-23 | 32 | 0 |
| K950777 | OXYGEN REGULATOR | Mada Medical Products, Inc. | 1995-04-14 | 52 | 0 |
| K930947 | PROMENADE | Mada Medical Products, Inc. | 1993-06-01 | 98 | 0 |
| K930949 | VOYAGE | Mada Medical Products, Inc. | 1993-06-01 | 98 | 0 |
| K921611 | MADAVAC 190 | Mada Medical Products, Inc. | 1992-09-09 | 159 | 0 |
| K850754 | MEDAJET XL - JET INJECTOR | Mada Medical Products, Inc. | 1985-12-10 | 288 | 0 |
| K802426 | RESPO2 OXYGEN CONCENTRATOR | Mada Medical Products, Inc. | 1980-10-23 | 17 | 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