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.

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
Combination Product No
PCCP Authorized No
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 162
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K042102.
P&P SAFETY SYRINGE
K043419 · Medexel Medical Mfg. Co., Ltd. · Apr 2005
INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE
K050131 · M.K. Meditech Co. , Ltd. · Apr 2005
ICC INSULIN SAFEPRO SAFETY SYRINGE
K050134 · Formosa Medical Devices, Inc. · Apr 2005
PROCEDUR SF SAFETY SYRINGE DEVICE
K042487 · Avanca Medical Devices, Inc. · Jan 2005
BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML
K043038 · Biotop Technology Co., Ltd. · Dec 2004
TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM
K042712 · Safety Syringes, Inc. · Oct 2004
K042102 · YIXIN SAFETY SYRINGE
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