Cleared Traditional

K990328 - DBC, DONG BANG ACUPUNCTURE NEEDLES

K990328 is an FDA 510(k) clearance for DBC, manufactured by Morning Star, Dong Bang Acupuncture U.S.A., Inc.. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K990328 · Morning Star, Dong Bang Acupuncture U.S.A., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
91d
Days
Class 2
Risk

K990328 is an FDA 510(k) clearance for the DBC, DONG BANG ACUPUNCTURE NEEDLES. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Morning Star, Dong Bang Acupuncture U.S.A., Inc. (South Pasadena, US). The FDA issued a Cleared decision on May 4, 1999 after a review of 91 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Morning Star, Dong Bang Acupuncture U.S.A., Inc. devices

FDA 510(k) Submission Details - K990328

510(k) Number K990328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1999
Decision Date May 04, 1999
Days to Decision 91 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
38d faster than avg
Panel avg: 129d · This submission: 91d
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 K990328.
KANGNIAN BRAND ACUPUNCTURE NEEDLE
K991507 · Helio Medical Supplies, Inc. · Aug 1999
ACUMASTER BRAND ACUPUNCTURE NEEDLE
K991508 · Helio Medical Supplies, Inc. · Aug 1999
FAMOUS PHYSICIANS BRAND DISPOSABLE ACUPUNCTURE NEEDLES
K990729 · Acc Intl. · May 1999
KINGLI ACUPUNCTURE NEEDLE
K990406 · United Pacific Co., Ltd. · Apr 1999
NATURAL BRAND ACUPUNCTURE NEEDLES
K983671 · Tcm Supply Corp. · Mar 1999
ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES
K981272 · Electro Therapeutic Devices, Inc. · Aug 1998