510(k) Report

FDA applicant

Wenzhou Longwan Medical Device Factory

Wenzhou, CN1 decision2024–20240 recalls

FDA records 1 decision for Wenzhou Longwan Medical Device Factory (Wenzhou, CN) in 2024: 1 510(k) clearance. All are in product code DXQ (Blood Pressure Cuff). Its devices cite 1 predicate, 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 Wenzhou Longwan Medical Device Factory’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024: 1
2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Wenzhou Longwan Medical Device Factory by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Wenzhou Longwan Medical Device Factory’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DXQBlood Pressure Cuff1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K240165Aneroid Sphygmomanometer with Stethoscope; Aneroid SphygmomanometerWenzhou Longwan Medical Device Factory · 2024

The one decision as Wenzhou Longwan Medical Device Factory →