Cleared Traditional

K000581 - MAEDA NEW NEEDLE DISPOSABLE

K000581 is an FDA 510(k) clearance for MAEDA NEW NEEDLE DISPOSABLE, 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 367-day FDA review.

K000581 · Maeda Toyokichi Shoten · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
367d
Days
Class 2
Risk

K000581 is an FDA 510(k) clearance for the MAEDA NEW NEEDLE DISPOSABLE. 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 February 23, 2001 after a review of 367 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K000581

510(k) Number K000581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2000
Decision Date February 23, 2001
Days to Decision 367 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
238d slower than avg
Panel avg: 129d · This submission: 367d
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 K000581.
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
MAC ACUPUNCTURE NEEDLE
K002827 · Haenglim Seowon Corp. · Feb 2001
HOLY DRAGON ACUPUNCTURE NEEDLES
K002910 · Anc Import & Export Co. , Ltd. · Feb 2001
TAI-CHI ACUPUNCTURE NEEDLES
K003760 · Lhasa Medical, Inc. · Feb 2001
TIANXIE
K003748 · Suzhou Tianyi Acupuncture Instruments Co., Ltd. · Jan 2001
K000581 · MAEDA NEW NEEDLE DISPOSABLE
Download PDF FDA Summary Maeda Toyokichi Shoten