Cleared Traditional

K162566 - AIK Sterile Acupuncture Needles for Single Use

K162566 is an FDA 510(k) clearance for AIK Sterile Acupuncture Needles for Sin..., manufactured by Changchun Aik Medical Devices Co., Ltd.. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K162566 · Changchun Aik Medical Devices Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K162566

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 129d · This submission: 239d
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 K162566.
Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles
K142760 · K.S. Choi Corporation · Aug 2015
EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural
K150903 · Maanshan Bond Medical Instruments Co., Ltd. · Jul 2015
KM Needles (Acupuncture Needle)
K142920 · K.M.S., Inc. · Jun 2015
SMC ACUPUNCTURE NEEDLE
K141473 · Smc Intl., Inc. · Aug 2014
CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE
K132896 · Asia-Med GmbH and CO KG · Dec 2013
WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE)
K111392 · Woojeon Company · Nov 2011
K162566 · AIK Sterile Acupuncture Needles for Single Use
Download PDF FDA Summary Changchun Aik Medical…