Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Windsor Medical, Inc. · Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

61 daysmedian FDA review time
198 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K841481WINDSOR MEDICAL MODEL 50-00002Windsor Medical, Inc.1984-05-21420
K832606WINDSOR MEDICAL VARIOUS MODELSWindsor Medical, Inc.1983-11-291180
K832641WINDSOR MEDICAL MODEL 52Windsor Medical, Inc.1983-10-04610
K830657AMBULATORY MARK XI DRUG INFUSION DEV-Windsor Medical, Inc.1983-09-161980
K830656AMBULATORY MARK III INFUSION DEVICEWindsor Medical, Inc.1983-08-161670
K830317INFUSION PUMP ACCESS. #60-01-5Windsor Medical, Inc.1983-03-31590
K830544WINDSOR MEDICAL, INC. 50-01-028Windsor Medical, Inc.1983-03-31370
K830490MODEL 50-01-27Windsor Medical, Inc.1983-03-31440
K822842AMBULATORY MARK IWindsor Medical, Inc.1983-03-241820

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