Cleared Traditional

K974122 - ACUPUNCTURE NEEDLE UNDER THE BRAND NAME...

K974122 is an FDA 510(k) clearance for ACUPUNCTURE NEEDLE UNDER THE BRAND NAME..., manufactured by Scientific Health Care. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K974122 · Scientific Health Care · General Hospital
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Jan 1998
Decision
83d
Days
Class 2
Risk

K974122 is an FDA 510(k) clearance for the ACUPUNCTURE NEEDLE UNDER THE BRAND NAME HWATO AND HUAXIA. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Scientific Health Care (Costa Mesa, US). The FDA issued a Cleared decision on January 22, 1998 after a review of 83 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.

View all Scientific Health Care devices

FDA 510(k) Submission Details - K974122

510(k) Number K974122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1997
Decision Date January 22, 1998
Days to Decision 83 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
46d faster than avg
Panel avg: 129d · This submission: 83d
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.