Atlas FDA

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

Infinium Medical — Predicate Candidate Screening

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

162 daysmedian FDA review time
218 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K142244CLEO PATIENT MONITORInfinium Medical2015-02-061770
K132229OMNI PATENT MONITORSInfinium Medical2014-02-212180
K112329OMNI PATIENT MONITORInfinium Medical2011-09-08270
K103737OMNI II PATIENT MONITORInfinium Medical2011-06-021620
K103268OMNI EXPRESSInfinium Medical2010-11-23190
K101052OMNI III PATIENT MONITORInfinium Medical2010-08-111180

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