Cleared Traditional

K142760 - Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles (FDA 510(k) Clearance)

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

K142760 · K.S. Choi Corporation · General Hospital
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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

Submission Details

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
206d slower than avg
Panel avg: 128d · This submission: 334d
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.