FDA applicant

Bontech, Inc.

Suwon-Si, KR5 decisions2016–20250 recalls

FDA records 5 decisions for Bontech, Inc. (Suwon-Si, KR) from 2016 to 2025: 5 510(k) clearances. Most are in product codes MQB (Solid State X-Ray Imager (Flat Panel/Digital…) and IZL (System, X-Ray, Mobile). Since 2016 its 510(k)s took a median of 37 days from receipt to decision, against 92 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Bontech Co., Ltd.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Bontech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2016high 2 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Bontech, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Bontech, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?