510(k) Report

FDA applicant

Chengdu Daxan Innovative Medical Tech. Co., Ltd.

Chengdu, CN2 decisions2022–20250 recalls

FDA records 2 decisions for Chengdu Daxan Innovative Medical Tech. Co., Ltd. (Chengdu, CN) from 2022 to 2025: 2 510(k) clearances. All are in product code EZD (Catheter, Straight). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Chengdu Daxan Innovative Medical Tech. Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2022: 12025: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Chengdu Daxan Innovative Medical Tech. Co., Ltd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Chengdu Daxan Innovative Medical Tech.…’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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