FDA applicant

Fuji Systems Corp.

Mccordsville, IN3 decisions2005–20220 recalls

FDA records 3 decisions for Fuji Systems Corp. (Mccordsville, IN) from 2005 to 2022: 3 510(k) clearances. Most are in product codes CBI (Tube, Tracheal/Bronchial, Differential…) and QJP (Catheter, Percutaneous, Neurovasculature). Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Fuji Systems Corporation”.

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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Fuji Systems Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Fuji Systems Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fuji Systems Corp.’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

Other applicant names beginning “Fuji”

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

Fuji Dynamics Limited 12 Fuji Optical Systems, Inc. 1 Fuji Film Medical Systems 1

Fuji Systems Corp.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Fuji”