Cleared Traditional

K111841 - SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE

K111841 is an FDA 510(k) clearance for SHIFENG DISPOSABLE SYRINGE WITH OR WITH..., manufactured by Chengdu Xinjin Shifeng Med Appratus Inst Co., Ltd.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K111841 · Chengdu Xinjin Shifeng Med Appratus Inst Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
246d
Days
Class 2
Risk

K111841 is an FDA 510(k) clearance for the SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Chengdu Xinjin Shifeng Med Appratus Inst Co., Ltd. (Chengdu City, CN). The FDA issued a Cleared decision on March 1, 2012 after a review of 246 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 Chengdu Xinjin Shifeng Med Appratus Inst Co., Ltd. devices

FDA 510(k) Submission Details - K111841

510(k) Number K111841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2011
Decision Date March 01, 2012
Days to Decision 246 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
117d slower than avg
Panel avg: 129d · This submission: 246d
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 354
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