FDA applicant

Toray Industries (America), Inc.

New York, NY20 decisions1986–20044 recalls

FDA records 20 decisions for Toray Industries (America), Inc. (New York, NY) from 1986 to 2004: 18 510(k) clearances and 2 original PMA approvals. Most are in product codes KDI (Dialyzer, High Permeability With Or Without…) and FJI (Dialyzer, Capillary, Hollow Fiber). Its devices cite 5 predicates, 2 of them its own earlier devices. 4 recalls are 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 Toray Industries (America), Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Toray Industries (America), Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Toray Industries (America), Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Toray Industries (America), 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

Other applicant names beginning “Toray”

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

Toray Industries, Inc. 1

Toray Industries (America), Inc.

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 “Toray”