Cleared Traditional

K002411 - SHENLING ACUPUNCTURE NEEDLES

K002411 is an FDA 510(k) clearance for SHENLING ACUPUNCTURE NEEDLES, manufactured by Shenling Medical Device Co., Ltd.. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K002411 · Shenling Medical Device Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
127d
Days
Class 2
Risk

K002411 is an FDA 510(k) clearance for the SHENLING ACUPUNCTURE NEEDLES. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Shenling Medical Device Co., Ltd. (Los Angeles, US). The FDA issued a Cleared decision on December 12, 2000 after a review of 127 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5580 - 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 - K002411

510(k) Number K002411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2000
Decision Date December 12, 2000
Days to Decision 127 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 129d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQX Device Classification - Class 2, Special Controls

Product Code MQX Needle, Acupuncture, Single Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5580
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 - MQX Needle, Acupuncture, Single Use

All 90
Devices cleared under the same product code (MQX) and FDA review panel - the closest regulatory comparables to K002411.
HOLY DRAGON ACUPUNCTURE NEEDLES
K002910 · Anc Import & Export Co. , Ltd. · Feb 2001
TAI-CHI ACUPUNCTURE NEEDLES
K003760 · Lhasa Medical, Inc. · Feb 2001
TIANXIE
K003748 · Suzhou Tianyi Acupuncture Instruments Co., Ltd. · Jan 2001
SPIRIT ACUPUNCTURE NEEDLE
K003010 · United Pacific Co., Ltd. · Oct 2000
MILLENNIA ACUPUNCTURE NEEDLE
K001718 · United Pacific Co., Ltd. · Jun 2000
SHARP BRAND ACUPUNCTURE NEEDLES
K000816 · Tcm Supply Corp. · May 2000
K002411 · SHENLING ACUPUNCTURE NEEDLES
Download PDF Shenling Medical Devi…