510(k) Report

FDA applicant

Asahi Iryoki Co., Ltd.

White Plains, NY1 decision2000–20000 recalls

FDA records 1 decision for Asahi Iryoki Co., Ltd. (White Plains, NY) in 2000: 1 510(k) clearance. All are in product code MQX (Needle, Acupuncture, Single Use). 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, general hospital panel, where it files most

How often FDA has decided Asahi Iryoki Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Asahi Iryoki Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Asahi Iryoki Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Asahi Iryoki Co., Ltd.’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 “Asahi”

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