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
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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.

View all Shenling Medical Device Co., Ltd. devices

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
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 48
Devices cleared under the same product code (MQX) and FDA review panel - the closest regulatory comparables to K002411.
C&G ACUPUNCTURE NEEDLE
K043277 · Helio Medical Supplies, Inc. · Feb 2005
ACUPUNCTURE NEEDLES
K041652 · C.A.I. Industries Corp. · Dec 2004
PRESS TACK NEEDLE
K042063 · Asia-Med GmbH & Co. Kg. - Werk Suhl · Oct 2004
SEDATELEC ASP ACUPUNCTURE NEEDLES
K983798 · Sedatelec · Aug 1999
DN ACUPUNTURE NEEDLES
K983800 · Sedatelec · Aug 1999
KANGNIAN BRAND ACUPUNCTURE NEEDLE
K991507 · Helio Medical Supplies, Inc. · Aug 1999