Cleared Traditional

K002827 - MAC ACUPUNCTURE NEEDLE

K002827 is an FDA 510(k) clearance for MAC ACUPUNCTURE NEEDLE, manufactured by Haenglim Seowon Corp.. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K002827 · Haenglim Seowon Corp. · General Hospital
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Feb 2001
Decision
170d
Days
Class 2
Risk

K002827 is an FDA 510(k) clearance for the MAC ACUPUNCTURE NEEDLE. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Haenglim Seowon Corp. (Flushing, US). The FDA issued a Cleared decision on February 28, 2001 after a review of 170 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 - K002827

510(k) Number K002827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2000
Decision Date February 28, 2001
Days to Decision 170 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
41d slower than avg
Panel avg: 129d · This submission: 170d
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 K002827.
HUANQIU AND SUPER (TWO BRANDS) STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE
K011242 · Acusupply, Inc. · Sep 2001
ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX)
K011808 · Asia-Med GmbH and CO KG · Jul 2001
BW ACUPUNCTURE NEEDLES
K011669 · H F Intl. Co. · Jul 2001
MAEDA NEW NEEDLE DISPOSABLE
K000581 · Maeda Toyokichi Shoten · Feb 2001
HOLY DRAGON ACUPUNCTURE NEEDLES
K002910 · Anc Import & Export Co. , Ltd. · Feb 2001
TAI-CHI ACUPUNCTURE NEEDLES
K003760 · Lhasa Medical, Inc. · Feb 2001
K002827 · MAC ACUPUNCTURE NEEDLE
Download PDF Haenglim Seowon Corp.