FDA applicant

KANEKA Corporation

Tokyo, JP11 decisions2011–20180 recalls

FDA records 11 decisions for KANEKA Corporation (Tokyo, JP) from 2011 to 2018: 11 510(k) clearances. Most are in product codes LIT (Catheter, Angioplasty, Peripheral, Transluminal) and LOX (Catheters, Transluminal Coronary Angioplasty…). Since 2016 its 510(k)s took a median of 115 days from receipt to decision, against 115 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Kaneka Corp.”.

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 KANEKA Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2011high 4 (2016) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — KANEKA Corporation by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like KANEKA Corporation’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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Other applicant names beginning “KANEKA”

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

Kaneka Pharma America, LLC 5 Kaneka Medical America, LLC 2 Kaneka Americas Holding, Inc. 1

KANEKA Corporation

Which product codes does it file in?

How long do its 510(k) reviews take?

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 “KANEKA”