Cleared Traditional

K103061 - BIOMATE STERILE ACUPUNCTURE NEEDLE

K103061 is an FDA 510(k) clearance for BIOMATE STERILE ACUPUNCTURE NEEDLE, manufactured by Biomate Medical Devices Technology Co., Ltd.. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K103061 · Biomate Medical Devices Technology Co., Ltd. · General Hospital
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Jun 2011
Decision
245d
Days
Class 2
Risk

K103061 is an FDA 510(k) clearance for the BIOMATE STERILE ACUPUNCTURE NEEDLE. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Biomate Medical Devices Technology Co., Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on June 20, 2011 after a review of 245 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 - K103061

510(k) Number K103061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2010
Decision Date June 20, 2011
Days to Decision 245 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
116d slower than avg
Panel avg: 129d · This submission: 245d
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 K103061.
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K103061 · BIOMATE STERILE ACUPUNCTURE NEEDLE
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