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

Versamed Medical Systems, Inc. — Predicate Candidate Screening

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

65 daysmedian FDA review time
259 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K081845IVENT101Versamed Medical Systems, Inc.2009-03-162590
K073694IVENT 2001 MRI CONDITIONALVersamed Medical Systems, Inc.2008-05-301510
K061627MODIFICATION TO I VENT 201Versamed Medical Systems, Inc.2006-06-29170
K053270IVENT 201Versamed Medical Systems, Inc.2006-01-27650
K052554MODIFICATION TO: IVENT 201 PORTABLE VENTILATORVersamed Medical Systems, Inc.2005-09-2370
K042468IVENT 201 PORTABLE VENTILATORVersamed Medical Systems, Inc.2004-11-17650

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