Atlas FDA

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

Mri Devices Corporation — Predicate Candidate Screening

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

24 daysmedian FDA review time
29 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K050622HRW-63-8 WRIST ARRAY COIL; HRW-127-8 WRIST ARRAY COILMri Devices Corporation2005-04-08290
K050621NVA-127-8-A NEUROVASCULAR ARRAY COILMri Devices Corporation2005-04-07280
K050514MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILSMri Devices Corporation2005-03-25240
K050299HRK-123 KNEE ARRAY COILMri Devices Corporation2005-02-24170
K042103NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COILMri Devices Corporation2004-08-16120

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