510(k) Report

FDA applicant

Gangan Medical Technology Jiangsu Co., Ltd.

Taizhou City, CN1 decision2020–20200 recalls

FDA records 1 decision for Gangan Medical Technology Jiangsu Co., Ltd. (Taizhou City, CN) in 2020: 1 510(k) clearance. All are in product code FMI (Needle, Hypodermic, Single Lumen). 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 Gangan Medical Technology Jiangsu Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2020: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Gangan Medical Technology Jiangsu Co., Ltd. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Gangan Medical Technology Jiangsu Co.…’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?

  • FMINeedle, Hypodermic, Single Lumen1decision

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?

  • K192464Injection Pen NeedleGangan Medical Technology Jiangsu Co., Ltd. · 2020

The one decision as Gangan Medical Technology Jiangsu Co., Ltd. →