Cleared Traditional

K011669 - BW ACUPUNCTURE NEEDLES

K011669 is an FDA 510(k) clearance for BW ACUPUNCTURE NEEDLES, manufactured by H F Intl. Co.. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K011669 · H F Intl. Co. · General Hospital
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Jul 2001
Decision
40d
Days
Class 2
Risk

K011669 is an FDA 510(k) clearance for the BW ACUPUNCTURE NEEDLES. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by H F Intl. Co. (Los Angeles, US). The FDA issued a Cleared decision on July 9, 2001 after a review of 40 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 - K011669

510(k) Number K011669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2001
Decision Date July 09, 2001
Days to Decision 40 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
89d faster than avg
Panel avg: 129d · This submission: 40d
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 K011669.
HOLY DRAGON STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE
K011247 · Acusupply, Inc. · Oct 2001
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
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
K011669 · BW ACUPUNCTURE NEEDLES
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