Cleared Traditional

K072778 - BRIO ACUPUNCTURE NEEDLES

K072778 is an FDA 510(k) clearance for BRIO ACUPUNCTURE NEEDLES, manufactured by Helio Medical Supplies, Inc.. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K072778 · Helio Medical Supplies, Inc. · General Hospital
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Nov 2007
Decision
52d
Days
Class 2
Risk

K072778 is an FDA 510(k) clearance for the BRIO ACUPUNCTURE NEEDLES. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Helio Medical Supplies, Inc. (San Jose, US). The FDA issued a Cleared decision on November 19, 2007 after a review of 52 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.

FDA 510(k) Submission Details - K072778

510(k) Number K072778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2007
Decision Date November 19, 2007
Days to Decision 52 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
77d faster than avg
Panel avg: 129d · This submission: 52d
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 K072778.
JIAJIAN ACUPUNCTURE NEEDLE
K090199 · Wuxi Jiajian Medical Instrument Co., Ltd. · Aug 2009
HANSO ACUPUNCTURE NEEDLE
K090910 · Hansol Medical Co. · Jun 2009
TCMNATURELMED, HEALTHCARE, BLOODCARE, BO'S ABDOMINAL
K071524 · Tcm World, Inc. · Apr 2008
PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES
K061517 · Prime Herbs Corporation · Nov 2006
LYRA ACUPUNCTURE NEEDLES
K062448 · Helio Medical Supplies, Inc. · Sep 2006
ASP TITANIUM
K060392 · Sedatelec · Apr 2006
K072778 · BRIO ACUPUNCTURE NEEDLES
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