Cleared Traditional

K980469 - KHT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE

K980469 is an FDA 510(k) clearance for KHT SOOJI NEEDLE, manufactured by American Institute of Koryo Hand Therapy. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K980469 · American Institute of Koryo Hand Therapy · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
56d
Days
Class 2
Risk

K980469 is an FDA 510(k) clearance for the KHT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by American Institute of Koryo Hand Therapy (Industry, US). The FDA issued a Cleared decision on April 3, 1998 after a review of 56 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 American Institute of Koryo Hand Therapy devices

FDA 510(k) Submission Details - K980469

510(k) Number K980469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1998
Decision Date April 03, 1998
Days to Decision 56 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 129d · This submission: 56d
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 12
Devices cleared under the same product code (MQX) and FDA review panel - the closest regulatory comparables to K980469.
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