Cleared Traditional

K042102 - YIXIN SAFETY SYRINGE

K042102 is an FDA 510(k) clearance for YIXIN SAFETY SYRINGE, manufactured by Jiangxi Sanxin (Eversincere) Medical Devices Group. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K042102 · Jiangxi Sanxin (Eversincere) Medical Devices Group · General Hospital
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Mar 2005
Decision
216d
Days
Class 2
Risk

K042102 is an FDA 510(k) clearance for the YIXIN SAFETY SYRINGE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Jiangxi Sanxin (Eversincere) Medical Devices Group (Nan Chang, Jiangxi, CN). The FDA issued a Cleared decision on March 8, 2005 after a review of 216 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 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. Standard predicate reliance. 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 Jiangxi Sanxin (Eversincere) Medical Devices Group devices

FDA 510(k) Submission Details - K042102

510(k) Number K042102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2004
Decision Date March 08, 2005
Days to Decision 216 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 129d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEG Device Classification - Class 2, Special Controls

Product Code MEG Syringe, Antistick
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 - MEG Syringe, Antistick

All 60
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K042102.
PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE
K063755 · Smiths Medical Asd, Inc. · Feb 2007
PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 432558
K061194 · Smiths Medical Asd, Inc. · Aug 2006
TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR
K051865 · Terumo Medical Corp. · Sep 2005
TERUMO SURGUARD SAFETY SYRINGE
K024249 · Terumo Medical Corp. · Feb 2003
UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE
K993996 · Univec, Inc. · Jul 2000
SOLOGUARD LOCKING PLUS SYRINGE
K993609 · Safeguard Medical Products, Inc. · Mar 2000