FDA applicant

Hakko Shoji Co., Ltd.

Cincinnati, OH3 decisions1997–20020 recalls

FDA records 3 decisions for Hakko Shoji Co., Ltd. (Cincinnati, OH) from 1997 to 2002: 3 510(k) clearances. Most are in product codes BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)) and GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 1 predicate, 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Hakko Shoji Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Hakko Shoji 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 “Hakko”

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

Hakko Medical Co., Ltd. 3

Hakko Shoji Co., Ltd.

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?

Other applicant names beginning “Hakko”