Cleared Traditional

K103587 - DISPOSABLE BLLOD COLLECTION NEEDLE

K103587 is an FDA 510(k) clearance for DISPOSABLE BLLOD COLLECTION NEEDLE, manufactured by Weihai Hongyu Medical Devices Co., Ltd.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K103587 · Weihai Hongyu Medical Devices Co., Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Apr 2011
Decision
120d
Days
Class 2
Risk

K103587 is an FDA 510(k) clearance for the DISPOSABLE BLLOD COLLECTION NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Weihai Hongyu Medical Devices Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on April 6, 2011 after a review of 120 days - within the typical 510(k) review window.

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 Weihai Hongyu Medical Devices Co., Ltd. devices

FDA 510(k) Submission Details - K103587

510(k) Number K103587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2010
Decision Date April 06, 2011
Days to Decision 120 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
9d faster than avg
Panel avg: 129d · This submission: 120d
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 338
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K103587.
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EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO
K091140 · Vidacare Corporation · Oct 2009