510(k) Report

FDA applicant

Dezhou Hengchang Medical Technology Co., Ltd.

Dezhou City, CN3 decisions2022–20220 recalls

FDA records 3 decisions for Dezhou Hengchang Medical Technology Co., Ltd. (Dezhou City, CN) in 2022: 3 510(k) clearances. All are in product code LYZ (Vinyl Patient Examination Glove). Since 2016 its 510(k)s took a median of 93 days from receipt to decision, against 100 for FDA’s reviews in the same codes and years. Its devices cite 3 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, general hospital panel, where it files most

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

FDA decisions per year

3in 2022

2022: 3
2022high 3 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

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

Planning a device like Dezhou Hengchang Medical Technology…’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 “Dezhou”

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