Atlas FDA

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

Invivo — Predicate Candidate Screening

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

38 daysmedian FDA review time
57 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K0919021.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHInvivo2009-08-21570
K082987HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COILInvivo2008-11-06300
K082916HRB-127-32 HIGH RESOLUTION BRAIN COILInvivo2008-10-15150
K072873LBS-63-16 BREAST ARRAY COILInvivo2007-11-16384
K072874LBS-127-16 BREAST ARRAY COILInvivo2007-11-16380
K061952CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CACInvivo2006-07-28180

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