Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Winmed Instruments Mfg. Corp. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
102 daysmedian FDA review time
230 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K942163 | WINNER SELF-TAKING HOME BLOOD PRESSURE KIT | Winmed Instruments Mfg. Corp. | 1994-12-20 | 230 | 0 |
| K892079 | CHAMP-PAQ VINYL PATIENT EXAM GLOVES | Winmed Instruments Mfg. Corp. | 1989-09-01 | 151 | 0 |
| K892097 | CHAMP-PAQ LATEX PATIENT EXAM GLOVES | Winmed Instruments Mfg. Corp. | 1989-07-14 | 102 | 0 |
| K893107 | CHAMP-PAQ LATEX PATIENT EXAMINATION GLOVES | Winmed Instruments Mfg. Corp. | 1989-06-19 | 66 | 0 |
| K892098 | CHAMP-PAQ VINYL PATIENT EXAM GLOVES | Winmed Instruments Mfg. Corp. | 1989-04-28 | 25 | 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