Cleared Traditional

K071524 - TCMNATURELMED

K071524 is an FDA 510(k) clearance for TCMNATURELMED, manufactured by Tcm World, Inc.. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 311-day FDA review.

K071524 · Tcm World, Inc. · General Hospital
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Apr 2008
Decision
311d
Days
Class 2
Risk

K071524 is an FDA 510(k) clearance for the TCMNATURELMED, HEALTHCARE, BLOODCARE, BO'S ABDOMINAL. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Tcm World, Inc. (San Gabriel, US). The FDA issued a Cleared decision on April 10, 2008 after a review of 311 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.

View all Tcm World, Inc. devices

FDA 510(k) Submission Details - K071524

510(k) Number K071524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2007
Decision Date April 10, 2008
Days to Decision 311 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
182d slower than avg
Panel avg: 129d · This submission: 311d
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.