Cleared Traditional

K991507 - KANGNIAN BRAND ACUPUNCTURE NEEDLE

K991507 is an FDA 510(k) clearance for KANGNIAN BRAND ACUPUNCTURE NEEDLE, manufactured by Helio Medical Supplies, Inc.. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K991507 · Helio Medical Supplies, Inc. · General Hospital
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Aug 1999
Decision
120d
Days
Class 2
Risk

K991507 is an FDA 510(k) clearance for the KANGNIAN BRAND ACUPUNCTURE NEEDLE. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Helio Medical Supplies, Inc. (Santa Clara, US). The FDA issued a Cleared decision on August 27, 1999 after a review of 120 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 Helio Medical Supplies, Inc. devices

FDA 510(k) Submission Details - K991507

510(k) Number K991507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1999
Decision Date August 27, 1999
Days to Decision 120 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
9d faster than avg
Panel avg: 129d · This submission: 120d
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 K991507.
SEDATELEC ASP ACUPUNCTURE NEEDLES
K983798 · Sedatelec · Aug 1999
DN ACUPUNTURE NEEDLES
K983800 · Sedatelec · Aug 1999
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
KINGLI ACUPUNCTURE NEEDLE
K990406 · United Pacific Co., Ltd. · Apr 1999