Cleared Traditional

K003760 - TAI-CHI ACUPUNCTURE NEEDLES

K003760 is an FDA 510(k) clearance for TAI-CHI ACUPUNCTURE NEEDLES, manufactured by Lhasa Medical, Inc.. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K003760 · Lhasa Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
62d
Days
Class 2
Risk

K003760 is an FDA 510(k) clearance for the TAI-CHI ACUPUNCTURE NEEDLES. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Lhasa Medical, Inc. (Weymouth, US). The FDA issued a Cleared decision on February 6, 2001 after a review of 62 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 - K003760

510(k) Number K003760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2000
Decision Date February 06, 2001
Days to Decision 62 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
67d faster than avg
Panel avg: 129d · This submission: 62d
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 K003760.
MAC ACUPUNCTURE NEEDLE
K002827 · Haenglim Seowon Corp. · Feb 2001
MAEDA NEW NEEDLE DISPOSABLE
K000581 · Maeda Toyokichi Shoten · Feb 2001
HOLY DRAGON ACUPUNCTURE NEEDLES
K002910 · Anc Import & Export Co. , Ltd. · Feb 2001
TIANXIE
K003748 · Suzhou Tianyi Acupuncture Instruments Co., Ltd. · Jan 2001
SHENLING ACUPUNCTURE NEEDLES
K002411 · Shenling Medical Device Co., Ltd. · Dec 2000
SPIRIT ACUPUNCTURE NEEDLE
K003010 · United Pacific Co., Ltd. · Oct 2000
K003760 · TAI-CHI ACUPUNCTURE NEEDLES
Download PDF FDA Summary Lhasa Medical, Inc.