Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FUJIFILM Healthcare Americas Corporation · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
168 daysmedian FDA review time
216 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261713 | Synapse PACS (7.6.0) | FUJIFILM Healthcare Americas Corporation | 2026-06-18 | 27 | 0 |
| K251204 | FUJIFILM Stiffening Wire Device (SW-2000) | FUJIFILM Healthcare Americas Corporation | 2025-09-26 | 161 | 0 |
| K243647 | Synapse PACS (7.5) | FUJIFILM Healthcare Americas Corporation | 2025-06-30 | 216 | 0 |
| K233321 | Double Balloon Endoscope EN-840T, Over-tube TS-1214C | FUJIFILM Healthcare Americas Corporation | 2024-06-13 | 258 | 0 |
| K233629 | APERTO Lucent MRI System | FUJIFILM Healthcare Americas Corporation | 2024-05-10 | 179 | 0 |
| K233687 | ECHELON Synergy V10.0 | FUJIFILM Healthcare Americas Corporation | 2024-05-03 | 168 | 0 |
| K233583 | FCT iSTREAM Phase 1 | FUJIFILM Healthcare Americas Corporation | 2024-04-26 | 171 | 0 |
| K240075 | FUJIFILM Endoscope Model EB-710XT | FUJIFILM Healthcare Americas Corporation | 2024-02-07 | 28 | 0 |
| K231666 | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasoni | FUJIFILM Healthcare Americas Corporation | 2023-12-13 | 189 | 0 |
| K231941 | ARIETTA x10 | FUJIFILM Healthcare Americas Corporation | 2023-11-20 | 143 | 0 |
| K231574 | Scenaria View 4.2 | FUJIFILM Healthcare Americas Corporation | 2023-10-12 | 134 | 0 |
| K230752 | Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-15 | FUJIFILM Healthcare Americas Corporation | 2023-09-15 | 182 | 0 |
| K232314 | Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) | FUJIFILM Healthcare Americas Corporation | 2023-09-01 | 30 | 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