Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Med-West, Inc. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
43 daysmedian FDA review time
69 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K880877 | CONTRAST INJECTION DEVICE | Med-West, Inc. | 1988-05-31 | 91 | 0 |
| K880398 | POWER TOILET ELEVATOR | Med-West, Inc. | 1988-03-17 | 48 | 0 |
| K874470 | MWI 400 WOUND DRESSING | Med-West, Inc. | 1987-12-18 | 46 | 0 |
| K872724 | SHEATH/DILATORS | Med-West, Inc. | 1987-09-15 | 69 | 0 |
| K854612 | ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7 | Med-West, Inc. | 1986-01-03 | 46 | 0 |
| K852162 | MNI 400 INJECTION CAPS | Med-West, Inc. | 1985-06-12 | 23 | 0 |
| K842342 | MWI 888 & 666 DOUBLE LUMEN SUBCLAVIAN | Med-West, Inc. | 1984-06-14 | 0 | 0 |
| K832124 | CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI | Med-West, Inc. | 1983-08-12 | 43 | 0 |
| K831828 | TEFLON FEMORAL CATHETER MWI 100,10 & | Med-West, Inc. | 1983-07-07 | 30 | 0 |
| K831401 | SINGLE NEEDLE SUBCLAVIAN VEIN ACCESS | Med-West, Inc. | 1983-06-03 | 32 | 0 |
| K831440 | SINGLE NEEDLE SUBCLAVIAN VEIN MWI250/260 | Med-West, Inc. | 1983-06-03 | 29 | 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