Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fujifilm Corporaton — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
191 daysmedian FDA review time
241 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221551 | FUJIFILM Endoscope Model EI-740D/S | Fujifilm Corporaton | 2023-01-27 | 241 | 0 |
| K223295 | Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, T | Fujifilm Corporaton | 2023-01-11 | 77 | 0 |
| K220957 | FUJIFILM Endoscope Model EB-710P | Fujifilm Corporaton | 2022-11-10 | 223 | 0 |
| K212950 | FUJIFILM Video Laparoscope EL-R740M30 | Fujifilm Corporaton | 2021-12-02 | 77 | 0 |
| K203717 | Processor VP-7000, Light Source BL-7000X, Image Processing U | Fujifilm Corporaton | 2021-06-30 | 191 | 0 |
| K200973 | Synapse 3D Cardiac Tools | Fujifilm Corporaton | 2020-08-27 | 136 | 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