510(k) Report

FDA applicant

Jiangsu Shenli Medical Production Factory

Mosely, VA1 decision2011–20112 recalls

FDA records 1 decision for Jiangsu Shenli Medical Production Factory (Mosely, VA) in 2011: 1 510(k) clearance. All are in product code FMF (Syringe, Piston). 2 recalls are 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 Factory’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

2in 2024

2024: 2
2011high 2 (2024) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Jiangsu Shenli Medical Production Factory by year, 2011–2026Sources: 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

What has FDA decided for it lately?

  • K103830Jiangsu Shenli Medical Production CO. LTD. Piston Syringe (5CC Luer Lock)Jiangsu Shenli Medical Production Factory · 20112 recalls

The one decision as Jiangsu Shenli Medical Production Factory →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K103830McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. 102-S60C -…Jul 24, 2024Class II
  • K103830Medline Convenience kits labeled as: 1) SYRINGE CNTRL 10ML RED L/L LP , Pack Number…Apr 8, 2024Class II