Cleared Traditional

K020880 - MARKNEW PRODUCTS ACUPUNCTURE NEEDLES

K020880 is an FDA 510(k) clearance for MARKNEW PRODUCTS ACUPUNCTURE NEEDLES, manufactured by Marknew Products. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K020880 · Marknew Products · General Hospital
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Jun 2002
Decision
84d
Days
Class 2
Risk

K020880 is an FDA 510(k) clearance for the MARKNEW PRODUCTS ACUPUNCTURE NEEDLES. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Marknew Products (Irvine, US). The FDA issued a Cleared decision on June 10, 2002 after a review of 84 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 - K020880

510(k) Number K020880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2002
Decision Date June 10, 2002
Days to Decision 84 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 faster than avg
Panel avg: 129d · This submission: 84d
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 K020880.
JIA CHEN ACUPUNCTURE NEEDLE, FOR SINGLE USE
K023054 · Mandala Health Care, LLC · Nov 2002
MAEDA SILVER ACUPUNCTURE NEEDLE
K021904 · Maeda Toyokichi Shoten · Aug 2002
QIZHOU ACUPUNCTURE NEEDLE
K013926 · Wujiang City Shenli Medical and Health Material CO · Jul 2002
HOLY DRAGON BRAND ACUPUNCTURE NEEDLES
K021095 · Wujiang City Hua Xin Medical Appliance Co., Ltd. · May 2002
H.M.T. ACUPUNCTURE NEEDLE
K012501 · Hummingbird Medical Technology, LLC · Dec 2001
ACUGLIDE BRAND ACUPUNCTURE NEEDLES
K012583 · Helio Medical Supplies, Inc. · Dec 2001
K020880 · MARKNEW PRODUCTS ACUPUNCTURE NEEDLES
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