510(k) Report

FDA applicant

Hangzhou Tappa Medical Technology Co., Ltd.

Hangzhou, CN3 decisions2026–20260 recalls

FDA records 3 decisions for Hangzhou Tappa Medical Technology Co., Ltd. (Hangzhou, CN) in 2026: 3 510(k) clearances. Most are in product codes DWJ (System, Thermal Regulating) and CBI (Tube, Tracheal/Bronchial, Differential…). Its devices cite 5 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, cardiovascular panel, where it files most

How often FDA has decided Hangzhou Tappa Medical Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2026

2026 (partial year): 3
2026high 3 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

FIG. 1 — Hangzhou Tappa Medical Technology Co., Ltd. by year, 2026–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hangzhou Tappa Medical Technology Co.…’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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