Cleared Special

K052085 - STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES

K052085 is an FDA 510(k) clearance for STANDARD, manufactured by Asia-Med GmbH and CO KG. The device is a Class 2 General Hospital device with product code MQX cleared through the Special 510(k) pathway after a 73-day FDA review.

K052085 · Asia-Med GmbH and CO KG · General Hospital
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Oct 2005
Decision
73d
Days
Class 2
Risk

K052085 is an FDA 510(k) clearance for the STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NE.... Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Asia-Med GmbH and CO KG (Littleton, US). The FDA issued a Cleared decision on October 14, 2005 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K052085

510(k) Number K052085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2005
Decision Date October 14, 2005
Days to Decision 73 days
Submission Type Special
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
Modification to existing cleared device.

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 K052085.
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K052085 · STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES
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