Cleared Traditional

K003010 - SPIRIT ACUPUNCTURE NEEDLE

K003010 is an FDA 510(k) clearance for SPIRIT ACUPUNCTURE NEEDLE, manufactured by United Pacific Co., Ltd.. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K003010 · United Pacific Co., Ltd. · General Hospital
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Oct 2000
Decision
23d
Days
Class 2
Risk

K003010 is an FDA 510(k) clearance for the SPIRIT ACUPUNCTURE NEEDLE. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by United Pacific Co., Ltd. (Alhambra, US). The FDA issued a Cleared decision on October 19, 2000 after a review of 23 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 - K003010

510(k) Number K003010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2000
Decision Date October 19, 2000
Days to Decision 23 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 129d · This submission: 23d
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 K003010.
TAI-CHI ACUPUNCTURE NEEDLES
K003760 · Lhasa Medical, Inc. · Feb 2001
TIANXIE
K003748 · Suzhou Tianyi Acupuncture Instruments Co., Ltd. · Jan 2001
SHENLING ACUPUNCTURE NEEDLES
K002411 · Shenling Medical Device Co., Ltd. · Dec 2000
MILLENNIA ACUPUNCTURE NEEDLE
K001718 · United Pacific Co., Ltd. · Jun 2000
SHARP BRAND ACUPUNCTURE NEEDLES
K000816 · Tcm Supply Corp. · May 2000
ASAHI STERILE ACUPUNCTURE NEEDLE TYPE S
K000740 · Asahi Iryoki Co., Ltd. · Apr 2000
K003010 · SPIRIT ACUPUNCTURE NEEDLE
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