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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Tanita Corp. of America · Predicate Candidate Screening

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

201 daysmedian FDA review time
634 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K040778TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHETanita Corp. of America2004-12-232720
K040978TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGTanita Corp. of America2004-07-22980
K033157TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418Tanita Corp. of America2004-04-081910
K014009TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TTanita Corp. of America2002-06-242010
K930599BODY FAT ANALYZER MODEL TBF-105Tanita Corp. of America1994-11-016340
K932572DIGITAL BABY SCALE MODEL BLB-12Tanita Corp. of America1993-11-161730

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