Cleared Special

K023787 - TAI-CHI AND MASTER ACUPUNCTURE NEEDLES

K023787 is an FDA 510(k) clearance for TAI-CHI AND MASTER ACUPUNCTURE NEEDLES, manufactured by Lhasa Medical, Inc.. The device is a Class 2 General Hospital device with product code MQX cleared through the Special 510(k) pathway after a 93-day FDA review.

K023787 · Lhasa Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
93d
Days
Class 2
Risk

K023787 is an FDA 510(k) clearance for the TAI-CHI AND MASTER ACUPUNCTURE NEEDLES. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Lhasa Medical, Inc. (Weymouth, US). The FDA issued a Cleared decision on February 14, 2003 after a review of 93 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Lhasa Medical, Inc. devices

FDA 510(k) Submission Details - K023787

510(k) Number K023787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2002
Decision Date February 14, 2003
Days to Decision 93 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 129d · This submission: 93d
Pathway characteristics
Modification to existing cleared device.

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 12
Devices cleared under the same product code (MQX) and FDA review panel - the closest regulatory comparables to K023787.
SINGER ACUPUNCTURE NEEDLES
K974616 · Lorac, Inc. · Feb 1998
ACUPUNCTURE NEEDLE UNDER THE BRAND NAME HWATO AND HUAXIA
K974122 · Scientific Health Care · Jan 1998
KHT SEOAM NEEDLE, HAND ACUPUNCTURE NEEDLE
K974527 · American Institute of Koryo Hand Therapy · Jan 1998
MAGI ACUPUNCTURE NEEDLES
K972658 · Dong Bang, U.S.A. · Oct 1997
DONG BANG ACUPUNCTURE NEEDLES
K972659 · Dong Bang, U.S.A. · Oct 1997
ACUPUNCTURE NEEDLES
K964861 · C.A.M. Supply, Inc. · May 1997