Cleared Traditional

K052723 - SEVEN STAR NEEDLE

K052723 is an FDA 510(k) clearance for SEVEN STAR NEEDLE, 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 106-day FDA review.

K052723 · Helio Medical Supplies, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
106d
Days
Class 2
Risk

K052723 is an FDA 510(k) clearance for the SEVEN STAR NEEDLE. 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 January 13, 2006 after a review of 106 days - within the typical 510(k) review window.

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 - K052723

510(k) Number K052723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2005
Decision Date January 13, 2006
Days to Decision 106 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
23d faster than avg
Panel avg: 129d · This submission: 106d
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 K052723.
LYRA ACUPUNCTURE NEEDLES
K062448 · Helio Medical Supplies, Inc. · Sep 2006
ASP TITANIUM
K060392 · Sedatelec · Apr 2006
KANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND ACUPUNCTURE NEEDLES
K052731 · Daxin LI · Feb 2006
TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USE
K052846 · Maanshan Medical Instruments Co., Ltd. · Dec 2005
STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES
K052085 · Asia-Med GmbH and CO KG · Oct 2005
PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES
K050295 · Helio Medical Supplies, Inc. · Mar 2005
K052723 · SEVEN STAR NEEDLE
Download PDF Helio Medical Supplie…