Cleared Traditional

K980472 - KHT SOFT NEEDLE, ACUPUNCTURE NEEDLE

K980472 is an FDA 510(k) clearance for KHT SOFT 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 62-day FDA review.

K980472 · American Institute of Koryo Hand Therapy · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
62d
Days
Class 2
Risk

K980472 is an FDA 510(k) clearance for the KHT SOFT NEEDLE, 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 9, 1998 after a review of 62 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 - K980472

510(k) Number K980472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1998
Decision Date April 09, 1998
Days to Decision 62 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 129d · This submission: 62d
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 K980472.
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
KHT SOFT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE
K980470 · American Institute of Koryo Hand Therapy · Apr 1998
KHT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE
K980469 · American Institute of Koryo Hand Therapy · Apr 1998
SINGER ACUPUNCTURE NEEDLES
K974616 · Lorac, Inc. · Feb 1998
K980472 · KHT SOFT NEEDLE, ACUPUNCTURE NEEDLE
Download PDF FDA Summary American Institute of…