510(k) Report

FDA applicant

Kung Shin Plastics Co., Ltd.

Hsin Chu City, TW1 decision2004–20042 recalls

FDA records 1 decision for Kung Shin Plastics Co., Ltd. (Hsin Chu City, TW) in 2004: 1 510(k) clearance. All are in product code CAH (Filter, Bacterial, Breathing-Circuit). 2 recalls are 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 Kung Shin Plastics Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kung Shin Plastics Co., Ltd. since 2007.

Recalls per year

2in 2025

2025: 2
2007high 2 (2025) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Kung Shin Plastics Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Kung”

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