Cleared Traditional

K000816 - SHARP BRAND ACUPUNCTURE NEEDLES

K000816 is an FDA 510(k) clearance for SHARP BRAND ACUPUNCTURE NEEDLES, manufactured by Tcm Supply Corp.. 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.

K000816 · Tcm Supply Corp. · General Hospital
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May 2000
Decision
52d
Days
Class 2
Risk

K000816 is an FDA 510(k) clearance for the SHARP BRAND ACUPUNCTURE NEEDLES. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Tcm Supply Corp. (City Of Industry, US). The FDA issued a Cleared decision on May 4, 2000 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.

View all Tcm Supply Corp. devices

FDA 510(k) Submission Details - K000816

510(k) Number K000816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2000
Decision Date May 04, 2000
Days to Decision 52 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
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 21
Devices cleared under the same product code (MQX) and FDA review panel - the closest regulatory comparables to K000816.
SEDATELEC ASP ACUPUNCTURE NEEDLES
K983798 · Sedatelec · Aug 1999
DN ACUPUNTURE NEEDLES
K983800 · Sedatelec · Aug 1999
NATURAL BRAND ACUPUNCTURE NEEDLES
K983671 · Tcm Supply Corp. · Mar 1999
ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES
K981272 · Electro Therapeutic Devices, Inc. · Aug 1998
JIN ACUPUNCTURE NEEDLES, MODELS ST, GL, SI, PT, AND ID
K980899 · Kenshin Trading Corp. · Jun 1998
KHT GUAM NEEDLE, ACUPUNCTURE NEEDLE
K980471 · American Institute of Koryo Hand Therapy · Apr 1998