Cleared Traditional

K142760 - Acuzone Acupuncture Needles

K142760 is an FDA 510(k) clearance for Acuzone Acupuncture Needles, manufactured by K.S. Choi Corporation. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 334-day FDA review.

K142760 · K.S. Choi Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
334d
Days
Class 2
Risk

K142760 is an FDA 510(k) clearance for the Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by K.S. Choi Corporation (Los Angeles, US). The FDA issued a Cleared decision on August 25, 2015 after a review of 334 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K.S. Choi Corporation devices

FDA 510(k) Submission Details - K142760

510(k) Number K142760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2014
Decision Date August 25, 2015
Days to Decision 334 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
205d slower than avg
Panel avg: 129d · This submission: 334d
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.