Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Milex Products, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
46 daysmedian FDA review time
77 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K001545 | PIPET CURET | Milex Products, Inc. | 2000-06-15 | 28 | 0 |
| K904774 | INGLAT-O-BALL | Milex Products, Inc. | 1990-12-07 | 46 | 14 |
| K904026 | INFLAT-O-BALL | Milex Products, Inc. | 1990-10-10 | 41 | 12 |
| K900903 | KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE | Milex Products, Inc. | 1990-05-03 | 65 | 0 |
| K882628 | ENDO C BRUSH | Milex Products, Inc. | 1988-07-25 | 28 | 0 |
| K862410 | MILEX KEGEL PERINEAL EXERCISER | Milex Products, Inc. | 1986-07-31 | 36 | 0 |
| K861385 | MILEX BARTHOLIN GLAND CATHETER | Milex Products, Inc. | 1986-06-16 | 63 | 0 |
| K760264 | CURETTE, PROPOSED TIS-U-TRAP, METAL | Milex Products, Inc. | 1976-10-06 | 77 | 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