Cleared Traditional

K073127 - BLOOD COLLECTION NEEDLE

K073127 is an FDA 510(k) clearance for BLOOD COLLECTION NEEDLE, 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 44-day FDA review.

K073127 · Shandong Weigao Group Medical Polymer Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
44d
Days
Class 2
Risk

K073127 is an FDA 510(k) clearance for the BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G. 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 December 20, 2007 after a review of 44 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shandong Weigao Group Medical Polymer Co., Ltd. devices

FDA 510(k) Submission Details - K073127

510(k) Number K073127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2007
Decision Date December 20, 2007
Days to Decision 44 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
85d faster than avg
Panel avg: 129d · This submission: 44d
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 K073127.
BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY
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K073188 · Smiths Medical Asd, Inc. · Feb 2008
STERICAN HYPODERMIC NEEDLES
K072247 · B.Braun Medical, Inc. · Nov 2007
ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT
K071998 · Arrow Intl., Inc. · Sep 2007
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE
K071785 · Smiths Medical Asd, Inc. · Aug 2007