FDA applicant

Asahi Polyslider Co., Ltd.

Maniwa, JP2 decisions2022–20220 recalls

FDA records 2 decisions for Asahi Polyslider Co., Ltd. (Maniwa, JP) in 2022: 2 510(k) clearances. Most are in product codes QRL (Multiple Use Blood Lancet For Single Patient…) and FMK (Single Use Only Blood Lancet With An Integral…). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 and plastic surgery panel, where it files most

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

FDA decisions per year

2in 2022

2022high 2 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Asahi Polyslider Co., Ltd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Asahi Polyslider 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.

Asahi Intecc Co., Ltd. 84 Asahi Medical Co., Ltd. 16 Asahi Kasei Medical Co., Ltd. 6 Asahi Optical Co. C/O Rosati Associates, P.C. 4 Asahi Intecc USA, Inc. 1 Asahi Iryoki Co., Ltd. 1 Asahi Kasei Pharma Corporation 1

Asahi Polyslider Co., Ltd.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Asahi”