Cleared Traditional

K150903 - EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural

K150903 is an FDA 510(k) clearance for EACU, manufactured by Maanshan Bond Medical Instruments Co., Ltd.. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K150903 · Maanshan Bond Medical Instruments Co., Ltd. · General Hospital
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Jul 2015
Decision
103d
Days
Class 2
Risk

K150903 is an FDA 510(k) clearance for the EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKI.... Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Maanshan Bond Medical Instruments Co., Ltd. (Maanshan, CN). The FDA issued a Cleared decision on July 15, 2015 after a review of 103 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.

FDA 510(k) Submission Details - K150903

510(k) Number K150903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2015
Decision Date July 15, 2015
Days to Decision 103 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
26d faster than avg
Panel avg: 129d · This submission: 103d
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 K150903.
AIK Sterile Acupuncture Needles for Single Use
K162566 · Changchun Aik Medical Devices Co., Ltd. · May 2017
Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles
K142760 · K.S. Choi Corporation · Aug 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
K150903 · EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural
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