FDA applicant

Kaneka Pharma America, LLC

New York, NY5 decisions1996–20201 recall

FDA records 5 decisions for Kaneka Pharma America, LLC (New York, NY) from 1996 to 2020: 4 510(k) clearances and 1 original PMA approval. Most are in product codes QEZ (Aspiration Thrombectomy Catheter) and MMY (Lipoprotein, Low Density, Removal). Its devices cite 5 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Kaneka Pharma America 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 Pharma America, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2022

2007high 1 (2022) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Kaneka Pharma America, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kaneka Pharma America, LLC’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 “Kaneka”

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

KANEKA Corporation 11 Kaneka Medical America, LLC 2 Kaneka Americas Holding, Inc. 1

Kaneka Pharma America, LLC

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?

What has been recalled?

Other applicant names beginning “Kaneka”