Cleared Traditional

K050999 - YI XIN STERILE SYRINGE FOR SINGLE USE

K050999 is an FDA 510(k) clearance for YI XIN STERILE SYRINGE FOR SINGLE USE, manufactured by Jiangxi Sanxin (Eversincere) Medical Devices Group. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K050999 · Jiangxi Sanxin (Eversincere) Medical Devices Group · General Hospital
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Sep 2005
Decision
135d
Days
Class 2
Risk

K050999 is an FDA 510(k) clearance for the YI XIN STERILE SYRINGE FOR SINGLE USE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Jiangxi Sanxin (Eversincere) Medical Devices Group (Nanchang, Jiangxi, CN). The FDA issued a Cleared decision on September 2, 2005 after a review of 135 days - within the typical 510(k) review window.

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 - K050999

510(k) Number K050999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2005
Decision Date September 02, 2005
Days to Decision 135 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
6d slower than avg
Panel avg: 129d · This submission: 135d
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 421
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K050999.
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