Cleared Traditional

K103061 - BIOMATE STERILE ACUPUNCTURE NEEDLE (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K103061 · Biomate Medical Devices Technology Co., Ltd. · General Hospital
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.

Submission Details

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
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 169d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.