Cleared Traditional

K990729 - FAMOUS PHYSICIANS BRAND DISPOSABLE ACUPUNCTURE NEEDLES

K990729 is an FDA 510(k) clearance for FAMOUS PHYSICIANS BRAND DISPOSABLE ACUP..., manufactured by Acc Intl.. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K990729 · Acc Intl. · General Hospital
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May 1999
Decision
69d
Days
Class 2
Risk

K990729 is an FDA 510(k) clearance for the FAMOUS PHYSICIANS BRAND DISPOSABLE ACUPUNCTURE NEEDLES. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Acc Intl. (Monterey Park, US). The FDA issued a Cleared decision on May 13, 1999 after a review of 69 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 Acc Intl. devices

FDA 510(k) Submission Details - K990729

510(k) Number K990729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1999
Decision Date May 13, 1999
Days to Decision 69 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
60d faster than avg
Panel avg: 129d · This submission: 69d
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 K990729.
DN ACUPUNTURE NEEDLES
K983800 · Sedatelec · Aug 1999
KANGNIAN BRAND ACUPUNCTURE NEEDLE
K991507 · Helio Medical Supplies, Inc. · Aug 1999
ACUMASTER BRAND ACUPUNCTURE NEEDLE
K991508 · Helio Medical Supplies, Inc. · Aug 1999
DBC, DONG BANG ACUPUNCTURE NEEDLES
K990328 · Morning Star, Dong Bang Acupuncture U.S.A., Inc. · May 1999
KINGLI ACUPUNCTURE NEEDLE
K990406 · United Pacific Co., Ltd. · Apr 1999
NATURAL BRAND ACUPUNCTURE NEEDLES
K983671 · Tcm Supply Corp. · Mar 1999