510(k) Report

FDA applicant

Jiangxi Kelun Medical Devices Manufacturing Co.,Lt

Wenzhou, Zhejiang, CN1 decision2014–20140 recalls

FDA records 1 decision for Jiangxi Kelun Medical Devices Manufacturing Co.,Lt (Wenzhou, Zhejiang, CN) in 2014: 1 510(k) clearance. All are in product code FMF (Syringe, Piston). 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, general hospital panel, where it files most

How often FDA has decided Jiangxi Kelun Medical Devices Manufacturing Co.,Lt’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Jiangxi Kelun Medical Devices Manufacturing Co.,Lt by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FMFSyringe, Piston1decision

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?

  • K133493Single Use Sterile Syringe with NeedleJiangxi Kelun Medical Devices Manufacturing Co.,Lt · 2014

The one decision as Jiangxi Kelun Medical Devices Manufacturing Co.,Lt →