Cleared Traditional

K990406 - KINGLI ACUPUNCTURE NEEDLE

K990406 is an FDA 510(k) clearance for KINGLI ACUPUNCTURE NEEDLE, manufactured by United Pacific Co., Ltd.. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K990406 · United Pacific Co., Ltd. · General Hospital
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Apr 1999
Decision
66d
Days
Class 2
Risk

K990406 is an FDA 510(k) clearance for the KINGLI ACUPUNCTURE NEEDLE. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by United Pacific Co., Ltd. (Alhambra, US). The FDA issued a Cleared decision on April 16, 1999 after a review of 66 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 United Pacific Co., Ltd. devices

FDA 510(k) Submission Details - K990406

510(k) Number K990406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1999
Decision Date April 16, 1999
Days to Decision 66 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
63d faster than avg
Panel avg: 129d · This submission: 66d
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 25
Devices cleared under the same product code (MQX) and FDA review panel - the closest regulatory comparables to K990406.
ACUMASTER BRAND ACUPUNCTURE NEEDLE
K991508 · Helio Medical Supplies, Inc. · Aug 1999
FAMOUS PHYSICIANS BRAND DISPOSABLE ACUPUNCTURE NEEDLES
K990729 · Acc Intl. · May 1999
DBC, DONG BANG ACUPUNCTURE NEEDLES
K990328 · Morning Star, Dong Bang Acupuncture U.S.A., Inc. · May 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