Cleared Traditional

K102328 - BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA

K102328 is an FDA 510(k) clearance for BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA, manufactured by Shandong Weigao Group Medical Polymer Co., Ltd.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K102328 · Shandong Weigao Group Medical Polymer Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
269d
Days
Class 2
Risk

K102328 is an FDA 510(k) clearance for the BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Shandong Weigao Group Medical Polymer Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on May 13, 2011 after a review of 269 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 Shandong Weigao Group Medical Polymer Co., Ltd. devices

FDA 510(k) Submission Details - K102328

510(k) Number K102328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2010
Decision Date May 13, 2011
Days to Decision 269 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
140d slower than avg
Panel avg: 129d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 282
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K102328.
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