Cleared Traditional

K021904 - MAEDA SILVER ACUPUNCTURE NEEDLE

K021904 is an FDA 510(k) clearance for MAEDA SILVER ACUPUNCTURE NEEDLE, manufactured by Maeda Toyokichi Shoten. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K021904 · Maeda Toyokichi Shoten · General Hospital
Download Printable Device Report (PDF)
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Aug 2002
Decision
65d
Days
Class 2
Risk

K021904 is an FDA 510(k) clearance for the MAEDA SILVER ACUPUNCTURE NEEDLE. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Maeda Toyokichi Shoten (Crofton, US). The FDA issued a Cleared decision on August 14, 2002 after a review of 65 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 - K021904

510(k) Number K021904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2002
Decision Date August 14, 2002
Days to Decision 65 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
64d faster than avg
Panel avg: 129d · This submission: 65d
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 K021904.
CARBO/OPTIMED BRAND ACUPUNCTURE NEEDLES
K030190 · Suzhou Sen Sen Medical Supplies , Ltd. · Feb 2003
TAI-CHI AND MASTER ACUPUNCTURE NEEDLES
K023787 · Lhasa Medical, Inc. · Feb 2003
JIA CHEN ACUPUNCTURE NEEDLE, FOR SINGLE USE
K023054 · Mandala Health Care, LLC · Nov 2002
QIZHOU ACUPUNCTURE NEEDLE
K013926 · Wujiang City Shenli Medical and Health Material CO · Jul 2002
MARKNEW PRODUCTS ACUPUNCTURE NEEDLES
K020880 · Marknew Products · Jun 2002
HOLY DRAGON BRAND ACUPUNCTURE NEEDLES
K021095 · Wujiang City Hua Xin Medical Appliance Co., Ltd. · May 2002
K021904 · MAEDA SILVER ACUPUNCTURE NEEDLE
Download PDF Maeda Toyokichi Shoten