510(k) Report

FDA applicant

Jiangsu Shenli Medical Production Co., Ltd.

Changzhou City, CN3 decisions2017–20200 recalls

FDA records 3 decisions for Jiangsu Shenli Medical Production Co., Ltd. (Changzhou City, CN) from 2017 to 2020: 3 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and PNR (Enteral Syringes With Enteral Specific…). Since 2016 its 510(k)s took a median of 130 days from receipt to decision, against 209 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 Jiangsu Shenli Medical Production Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2017: 12018: 12020: 1
2017high 1 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Jiangsu Shenli Medical Production Co., Ltd. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FMINeedle, Hypodermic, Single Lumen2decisions
  • PNREnteral Syringes With Enteral Specific Connectors1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 130 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 209 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K200557Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)Jiangsu Shenli Medical Production Co., Ltd. · 2020
  • K180259Sterile Hypodermic Needle for Single UseJiangsu Shenli Medical Production Co., Ltd. · 2018
  • K163093Safety Blood Collection SetJiangsu Shenli Medical Production Co., Ltd. · 2017

All 3 as Jiangsu Shenli Medical Production Co., Ltd. →