510(k) Report

FDA applicant

Fujifilm Corporaton

Ashigara Kami-Gun, JP6 decisions2020–20230 recalls

FDA records 6 decisions for Fujifilm Corporaton (Ashigara Kami-Gun, JP) from 2020 to 2023: 6 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 191 days from receipt to decision, against 116 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Fujifilm Corporaton’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2020: 12021: 22022: 12023: 2
2020high 2 (2021) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Fujifilm Corporaton by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fujifilm Corporaton’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GCJLaparoscope, General & Plastic Surgery2decisions
  • LLZSystem, Image Processing, Radiological1decision
  • EOQBronchoscope (Flexible Or Rigid)1decision
  • FDSGastroscope And Accessories, Flexible/Rigid1decision
  • FDAEnteroscope And Accessories1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 191 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 116 days; 1 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K220957FUJIFILM Endoscope Model EB-710PFujifilm Corporaton · 20223cite it
  • K200973Synapse 3D Cardiac ToolsFujifilm Corporaton · 20202cite it
  • K221551FUJIFILM Endoscope Model EI-740D/SFujifilm Corporaton · 20232cite it
  • K203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton · 20212cite it
  • K223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFujifilm Corporaton · 20231cites it

What has FDA decided for it lately?

  • K221551FUJIFILM Endoscope Model EI-740D/SFujifilm Corporaton · 2023
  • K223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFujifilm Corporaton · 2023
  • K220957FUJIFILM Endoscope Model EB-710PFujifilm Corporaton · 2022
  • K212950FUJIFILM Video Laparoscope EL-R740M30Fujifilm Corporaton · 2021
  • K203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton · 2021
  • K200973Synapse 3D Cardiac ToolsFujifilm Corporaton · 2020

All 6 as Fujifilm Corporaton →

Other applicant names beginning “Fujifilm”

FDA records each applicant name separately; these may or may not be the same firm.

Fujifilm Medical System U.S.A., Inc. 72Fujifilm Corporation 71Fujifilm Medical Systems U.S.A, Inc. 40FUJIFILM Sonosite, Inc. 25FUJIFILM Healthcare Americas Corporation 13Fujifilm Healthcare Corporation 6Fujifilm Irvine Scientific 5Fujifilm New Development U.S.A., Inc. 3Fujifilm Medwork GmbH 2Fujifilm Meidcal Systems U.S.A.,Inc. 2