510(k) Report

FDA applicant

Fujifilm New Development U.S.A., Inc.

Waltham, MA3 decisions2017–20180 recalls

FDA records 3 decisions for Fujifilm New Development U.S.A., Inc. (Waltham, MA) from 2017 to 2018: 3 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and FET (Endoscopic Video Imaging System/Component…). Since 2016 its 510(k)s took a median of 98 days from receipt to decision, against 77 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 1 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 New Development U.S.A., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2017: 22018: 1
2017high 2 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Fujifilm New Development U.S.A., Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • GCJLaparoscope, General & Plastic Surgery2decisions
  • FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 98 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 77 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K162836FUJIFILM Surgical SystemFujifilm New Development U.S.A., Inc. · 20172cite it

What has FDA decided for it lately?

  • K180414EPX-4440FN Digital Video Processor with Light SourceFujifilm New Development U.S.A., Inc. · 2018
  • K162836FUJIFILM Surgical SystemFujifilm New Development U.S.A., Inc. · 2017
  • K170084InterLock TrocarFujifilm New Development U.S.A., Inc. · 2017

All 3 as Fujifilm New Development U.S.A., Inc. →

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 Corporaton 6Fujifilm Irvine Scientific 5Fujifilm Medwork GmbH 2Fujifilm Meidcal Systems U.S.A.,Inc. 2