Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fuji Dynamics , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
145 daysmedian FDA review time
262 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161055 | Fuji Dynamics Incontinence Stimulation Electrode, Models Fuj | Fuji Dynamics , Ltd. | 2016-07-12 | 89 | 0 |
| K152676 | FD TENS 2090, FD TENS 2095 | Fuji Dynamics , Ltd. | 2016-01-22 | 126 | 0 |
| K152374 | LL TENS 160A, LL TENS 160B | Fuji Dynamics , Ltd. | 2016-01-13 | 145 | 0 |
| K111654 | FD TENS 2070 | Fuji Dynamics , Ltd. | 2012-03-01 | 262 | 0 |
| K111645 | FD TENS 2050 OR SLIDE TENS MODEL FD2050 | Fuji Dynamics , Ltd. | 2011-11-09 | 149 | 0 |
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