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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 677
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K021993.
KACEY INSULIN SYRINGE
K033166 · Kacey, Inc. · Dec 2003
NIPRO DISPOSABLE SYRINGES
K030683 · Nipro Medical Corp. · Oct 2003
AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE
K031394 · American Syringe Company · Jul 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
K021993 · SHANCHUAN SYRINGE
Download PDF FDA Summary Shangdong Zibo Shanch…