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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

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
Combination Product No
PCCP Authorized No
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 633
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K103587.
K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE
K110527 · Terumo Europe N.V. · Jun 2011
BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA
K102328 · Shandong Weigao Group Medical Polymer Co., Ltd. · May 2011
BD PEN NEEDLE
K110105 · Becton, Dickinson and Company (BD) · Apr 2011
IMC HYPODERMIC NEEDLE
K102584 · International Medsurg Connection · Jan 2011
CLICKFINE PEN NEEDLE
K102108 · Ypsomed AG · Nov 2010
VACUETTE PREMIUM SAFETY BLOOD COLLECTION SET
K102010 · Medpro Safety Products, Inc. · Nov 2010
K103587 · DISPOSABLE BLLOD COLLECTION NEEDLE
Download PDF FDA Summary Weihai Hongyu Medical…