Cleared Traditional

K042063 - PRESS TACK NEEDLE

K042063 is an FDA 510(k) clearance for PRESS TACK NEEDLE, manufactured by Asia-Med GmbH & Co. Kg. - Werk Suhl. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K042063 · Asia-Med GmbH & Co. Kg. - Werk Suhl · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
73d
Days
Class 2
Risk

K042063 is an FDA 510(k) clearance for the PRESS TACK NEEDLE. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Asia-Med GmbH & Co. Kg. - Werk Suhl (Littleton, US). The FDA issued a Cleared decision on October 14, 2004 after a review of 73 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 - K042063

510(k) Number K042063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2004
Decision Date October 14, 2004
Days to Decision 73 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
56d faster than avg
Panel avg: 129d · This submission: 73d
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 K042063.
ACUPUNCTURE NEEDLES
K043506 · Marknew Products · Feb 2005
C&G ACUPUNCTURE NEEDLE
K043277 · Helio Medical Supplies, Inc. · Feb 2005
ACUPUNCTURE NEEDLES
K041652 · C.A.I. Industries Corp. · Dec 2004
FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE
K031818 · Facilai Enterprises , Ltd. · Dec 2003
DBC PRESS ACUPUNCTURE NEEDLES
K031250 · Lhasa Medical, Inc. · Jul 2003
NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES
K031060 · Lhasa Medical, Inc. · Jul 2003
K042063 · PRESS TACK NEEDLE
Download PDF Asia-Med GmbH & Co. K…