Cleared Traditional

K031818 - FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE

K031818 is an FDA 510(k) clearance for FACILAI VARIOUS MODELS OF SINGLE USE AC..., manufactured by Facilai Enterprises , Ltd.. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K031818 · Facilai Enterprises , Ltd. · General Hospital
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Dec 2003
Decision
174d
Days
Class 2
Risk

K031818 is an FDA 510(k) clearance for the FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Facilai Enterprises , Ltd. (Hsin Chu City, TW). The FDA issued a Cleared decision on December 3, 2003 after a review of 174 days - an extended review 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: 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 - K031818

510(k) Number K031818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2003
Decision Date December 03, 2003
Days to Decision 174 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
45d slower than avg
Panel avg: 129d · This submission: 174d
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 K031818.
C&G ACUPUNCTURE NEEDLE
K043277 · Helio Medical Supplies, Inc. · Feb 2005
ACUPUNCTURE NEEDLES
K041652 · C.A.I. Industries Corp. · Dec 2004
PRESS TACK NEEDLE
K042063 · Asia-Med GmbH & Co. Kg. - Werk Suhl · Oct 2004
DBC PRESS ACUPUNCTURE NEEDLES
K031250 · Lhasa Medical, Inc. · Jul 2003
NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES
K031060 · Lhasa Medical, Inc. · Jul 2003
SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE
K031716 · Asia-Med GmbH and CO KG · Jul 2003
K031818 · FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE
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