Atlas FDA

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

Bio-Medical Research Corp. — Predicate Candidate Screening

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

17 daysmedian FDA review time
268 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K071666SLENDERTONE ENERVIVE, MODEL 561Bio-Medical Research Corp.2008-03-122680
K070142SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYBio-Medical Research Corp.2007-03-23660
K840149BMR POWERSTIMBio-Medical Research Corp.1984-01-30170
K840147BMR-2 MUSCLE STIMULATORBio-Medical Research Corp.1984-01-30170
K840148BMR-16 CLINIC MUSCLE STIMULATORBio-Medical Research Corp.1984-01-30170

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