510(k) Report

FDA applicant

Devon Medical Products (Jiangsu), Ltd.

Nantong, CN6 decisions2017–20190 recalls

FDA records 6 decisions for Devon Medical Products (Jiangsu), Ltd. (Nantong, CN) from 2017 to 2019: 6 510(k) clearances. All are in product code JOW (Sleeve, Limb, Compressible). Since 2016 its 510(k)s took a median of 124 days from receipt to decision, against 116 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, cardiovascular panel, where it files most

How often FDA has decided Devon Medical Products (Jiangsu), Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2017: 22018: 22019: 2
2017high 2 (2017) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Devon Medical Products (Jiangsu), Ltd. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Devon Medical Products (Jiangsu), 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 “Devon”

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