Cleared Abbreviated

K103830 - JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK)

K103830 is an FDA 510(k) clearance for JIANGSU SHENLI MEDICAL PRODUCTION CO. L..., manufactured by Jiangsu Shenli Medical Production Factory. The device is a Class 2 General Hospital device with product code FMF cleared through the Abbreviated 510(k) pathway after a 211-day FDA review.

K103830 · Jiangsu Shenli Medical Production Factory · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
211d
Days
Class 2
Risk

K103830 is an FDA 510(k) clearance for the JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK). Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Jiangsu Shenli Medical Production Factory (Mosely, US). The FDA issued a Cleared decision on July 29, 2011 after a review of 211 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K103830

510(k) Number K103830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2010
Decision Date July 29, 2011
Days to Decision 211 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 129d · This submission: 211d
Pathway characteristics
Standards-based clearance path.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 621
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K103830.
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MERIT MEDICAL 20 ML SYRINGE
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K103736 · Dmc Medical, Ltd. · Jun 2011
K103830 · JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK)
Download PDF FDA Summary Jiangsu Shenli Medica…