Cleared Traditional

K162566 - AIK Sterile Acupuncture Needles for Single Use (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K162566 · Changchun Aik Medical Devices Co., Ltd. · General Hospital
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May 2017
Decision
239d
Days
Class 2
Risk

K162566 is an FDA 510(k) clearance for the AIK Sterile Acupuncture Needles for Single Use. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Changchun Aik Medical Devices Co., Ltd. (Changchun, CN). The FDA issued a Cleared decision on May 11, 2017 after a review of 239 days - an extended review cycle.

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 Changchun Aik Medical Devices Co., Ltd. devices

Submission Details

510(k) Number K162566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2016
Decision Date May 11, 2017
Days to Decision 239 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
111d slower than avg
Panel avg: 128d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.