Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Western Medical, Ltd. · 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) |
|---|---|---|---|---|---|
| K894387 | WESTCO MADAYAG PAB NEEDLE | Western Medical, Ltd. | 1989-11-07 | 113 | 0 |
| K891459 | STERILE BURNNET PRE-CUT (VARIOUS SIZES) | Western Medical, Ltd. | 1989-05-26 | 72 | 0 |
| K840881 | WATER FLOATION BED 800/TC/H | Western Medical, Ltd. | 1984-07-18 | 142 | 0 |
| K840882 | HOME CARE WATER FLOTATION BED HC4/TC/H | Western Medical, Ltd. | 1984-07-18 | 142 | 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