Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fujifilm Corporation — Predicate Candidate Screening
66 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
128 daysmedian FDA review time
264 days90th percentile
66clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260567 | EW10-EC02 Endoscopy Support Program | Fujifilm Corporation | 2026-08-07 | 169 | 0 |
| K261880 | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscop | Fujifilm Corporation | 2026-07-02 | 27 | 0 |
| K253137 | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model E | Fujifilm Corporation | 2026-06-16 | 264 | 0 |
| K254075 | Synapse Lung Nodule AI | Fujifilm Corporation | 2026-05-27 | 160 | 0 |
| K254189 | Synapse 3D Base Tools (V7.2) | Fujifilm Corporation | 2026-04-30 | 128 | 0 |
| K253862 | APERTO Lucent MRI System | Fujifilm Corporation | 2026-04-06 | 124 | 0 |
| K251861 | FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model | Fujifilm Corporation | 2026-03-09 | 265 | 0 |
| K250550 | FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit | Fujifilm Corporation | 2026-02-17 | 357 | 0 |
| K253568 | Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114S | Fujifilm Corporation | 2026-02-06 | 81 | 0 |
| K250863 | FUJIFILM Ultrasonic Endoscope EB-710US | Fujifilm Corporation | 2025-12-12 | 266 | 0 |
| K251386 | ECHELON Synergy | Fujifilm Corporation | 2025-09-17 | 135 | 0 |
| K244017 | FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 | Fujifilm Corporation | 2025-06-13 | 168 | 0 |
| K243512 | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model E | Fujifilm Corporation | 2025-06-10 | 210 | 0 |
| K243261 | FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model | Fujifilm Corporation | 2025-05-23 | 220 | 0 |
| K243762 | Synapse 3D Base Tools (V7.0) | Fujifilm Corporation | 2025-05-21 | 166 | 0 |
| K250370 | SCENARIA View Phase 5.0 | Fujifilm Corporation | 2025-05-20 | 99 | 0 |
| K243260 | FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R | Fujifilm Corporation | 2025-04-11 | 178 | 0 |
| K243091 | Over-tube (TR-1108A) | Fujifilm Corporation | 2024-11-01 | 32 | 0 |
| K242779 | Hood (DH-083ST) | Fujifilm Corporation | 2024-10-11 | 28 | 0 |
| K240142 | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model E | Fujifilm Corporation | 2024-09-04 | 230 | 0 |
| K230751 | EW10-EC02 Endoscopy Support Program | Fujifilm Corporation | 2023-12-15 | 273 | 0 |
| K223827 | FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Prog | Fujifilm Corporation | 2023-09-08 | 261 | 0 |
| K221677 | Synapse 3D Base Tools v6.6 | Fujifilm Corporation | 2022-11-10 | 154 | 0 |
| K221238 | FUJIFILM Ultrasonic Endoscope EG-740UT | Fujifilm Corporation | 2022-08-19 | 112 | 0 |
| K221952 | Endoscope Model EG-580UT and Endoscope Model EG-580UR | Fujifilm Corporation | 2022-08-04 | 30 | 0 |
| K214089 | FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic | Fujifilm Corporation | 2022-06-03 | 157 | 0 |
| K212873 | Aspire Cristalle | Fujifilm Corporation | 2022-05-27 | 260 | 0 |
| K220053 | Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI | Fujifilm Corporation | 2022-02-04 | 29 | 0 |
| K212956 | FDR Cross (DR-XD 3000) | Fujifilm Corporation | 2021-11-08 | 53 | 0 |
| K213195 | Balloon BS-3 | Fujifilm Corporation | 2021-10-29 | 30 | 0 |
| K212296 | Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2 | Fujifilm Corporation | 2021-08-19 | 28 | 0 |
| K210162 | Endoscope Model EI-740D/S | Fujifilm Corporation | 2021-04-09 | 78 | 0 |
| K203103 | Synapse 3D, Synapse 3D Base Tools v6.1 | Fujifilm Corporation | 2021-02-09 | 118 | 0 |
| K203028 | FUJIFILM Distal End Cap | Fujifilm Corporation | 2020-10-30 | 28 | 0 |
| K202130 | FUJIFILM Video Laparoscope | Fujifilm Corporation | 2020-08-20 | 20 | 0 |
| K200850 | Fujifilm Ultrasonic Processor | Fujifilm Corporation | 2020-07-06 | 97 | 0 |
| K192286 | FUJIFILM EP-6000 Video Processor | Fujifilm Corporation | 2020-05-01 | 253 | 0 |
| K200668 | DR-ID 1200SDK System | Fujifilm Corporation | 2020-04-10 | 28 | 0 |
| K192918 | Video Laparoscope, Video Processor, Light Source | Fujifilm Corporation | 2020-02-20 | 128 | 0 |
| K193123 | FUJIFILM Distal Cap Models 33-40 | Fujifilm Corporation | 2019-12-11 | 29 | 0 |
| K192664 | FUJIFILM Endoscope Model EC-760Z-V/L | Fujifilm Corporation | 2019-11-20 | 56 | 0 |
| K192932 | FDR D-EVO III flat panel detector system | Fujifilm Corporation | 2019-11-12 | 26 | 0 |
| K192440 | FDR SE Lite | Fujifilm Corporation | 2019-11-01 | 56 | 0 |
| K191544 | Synapse 3D Blood Flow Analysis | Fujifilm Corporation | 2019-10-18 | 129 | 0 |
| K191747 | FUJIFILM Duodenoscope Model ED-580XT | Fujifilm Corporation | 2019-09-27 | 88 | 0 |
| K183433 | FUJIFILM Ultrasonic Endoscope | Fujifilm Corporation | 2019-09-05 | 268 | 0 |
| K183607 | FUJIFILM Bronchoscope | Fujifilm Corporation | 2019-08-23 | 240 | 0 |
| K183572 | FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/ | Fujifilm Corporation | 2019-07-16 | 207 | 0 |
| K191495 | Biopsy Positioner | Fujifilm Corporation | 2019-07-03 | 28 | 0 |
| K183032 | FUJIFILM Double Balloon Endoscope EI580BT | Fujifilm Corporation | 2019-06-24 | 235 | 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