Cleared Traditional

K141473 - SMC ACUPUNCTURE NEEDLE

K141473 is an FDA 510(k) clearance for SMC ACUPUNCTURE NEEDLE, manufactured by Smc Intl., Inc.. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K141473 · Smc Intl., Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
59d
Days
Class 2
Risk

K141473 is an FDA 510(k) clearance for the SMC ACUPUNCTURE NEEDLE. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Smc Intl., Inc. (Seoul, KR). The FDA issued a Cleared decision on August 1, 2014 after a review of 59 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K141473

510(k) Number K141473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2014
Decision Date August 01, 2014
Days to Decision 59 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
70d faster than avg
Panel avg: 129d · This submission: 59d
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 K141473.
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
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
BIOMATE STERILE ACUPUNCTURE NEEDLE
K103061 · Biomate Medical Devices Technology Co., Ltd. · Jun 2011
K141473 · SMC ACUPUNCTURE NEEDLE
Download PDF FDA Summary Smc Intl., Inc.