Atlas FDA

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

Iradimed Corporation · Predicate Candidate Screening

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

96 daysmedian FDA review time
751 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation2025-05-282580
K1809033880 MRI Patient Monitoring SystemIradimed Corporation2019-03-293570
K1829003880 MRI Patient Monitoring SystemIradimed Corporation2018-12-14590
K1722003880 MRI Patient Monitoring SystemIradimed Corporation2017-10-25960
K143369MRidium 3860+ MRI infusion Pump/ Monitoring SystemIradimed Corporation2016-12-157511
K090087MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEMIradimed Corporation2009-04-07842
K050301MRIDIUM 3850 MRI PUMP SYSTEMIradimed Corporation2005-03-24442

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