Cleared Traditional

K021993 - SHANCHUAN SYRINGE

K021993 is an FDA 510(k) clearance for SHANCHUAN SYRINGE, manufactured by Shangdong Zibo Shanchuan Medical Instruments Co.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 350-day FDA review.

K021993 · Shangdong Zibo Shanchuan Medical Instruments Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
350d
Days
Class 2
Risk

K021993 is an FDA 510(k) clearance for the SHANCHUAN SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Shangdong Zibo Shanchuan Medical Instruments Co. (Houston, US). The FDA issued a Cleared decision on June 3, 2003 after a review of 350 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Shangdong Zibo Shanchuan Medical Instruments Co. devices

FDA 510(k) Submission Details - K021993

510(k) Number K021993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2002
Decision Date June 03, 2003
Days to Decision 350 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
221d slower than avg
Panel avg: 129d · This submission: 350d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 375
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K021993.
SMITH & NEPHEW GRAFT DELIVERY SYSTEM
K041976 · Smith & Nephew, Inc. · Aug 2004
VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT
K033721 · Vascular Solutions, Inc. · Feb 2004
NIPRO DISPOSABLE SYRINGES
K030683 · Nipro Medical Corp. · Oct 2003
IMBIBE II SYRINGE
K030208 · Orthovita, Inc. · Apr 2003
IMBIBE BONE MARROW ASPIRATION SYRINGE
K023074 · Orthovita, Inc. · Mar 2003
MERIT MEDICAL 1-ML SYRINGE
K024052 · Merit Medical Systems, Inc. · Feb 2003