Atlas FDA

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

Fuji Dynamics Limited — Predicate Candidate Screening

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

119 daysmedian FDA review time
371 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K092780INF 4160 PLUS, MODEL D-FJ31FFuji Dynamics Limited2010-01-071190
K063642FD EMS, MODEL # D-FJ30EFuji Dynamics Limited2007-12-133710
K052813FD TENS 2030, MODEL DFJ24TFuji Dynamics Limited2006-01-251130
K043407INF 4160, MODEL D-FJ27FFuji Dynamics Limited2005-02-11630
K041164L-TENSFuji Dynamics Limited2004-05-20170
K994265MEDISANA DIGITAL TENSFuji Dynamics Limited2000-07-062020
K994266FDTENS 2010Fuji Dynamics Limited2000-07-062020

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