FDA applicant

The Standard Co., Ltd.

Gunpo-Si, KR2 decisions2022–20240 recalls

FDA records 2 decisions for The Standard Co., Ltd. (Gunpo-Si, KR) from 2022 to 2024: 2 510(k) clearances. All are in product code PLL (Submucosal Injection Agent). Its devices cite 2 predicates, 1 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2024

2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

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

Planning a device like The Standard 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 “The”

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

Standard Textile Co., Inc. 23 Standard Bariatrics 12 Standard Imaging, Inc. 10 Standard Diagnostics, Inc. 3 Standard Welders Supply Co. 3 Standard Surgical 1 Standard Engineering 1 Standard Scientific, Inc. 1

The Standard Co., Ltd.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “The”