Cleared Traditional

K981272 - ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES

K981272 is an FDA 510(k) clearance for ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES, manufactured by Electro Therapeutic Devices, Inc.. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K981272 · Electro Therapeutic Devices, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
139d
Days
Class 2
Risk

K981272 is an FDA 510(k) clearance for the ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Electro Therapeutic Devices, Inc. (Markham, Ontario, CA). The FDA issued a Cleared decision on August 24, 1998 after a review of 139 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 Electro Therapeutic Devices, Inc. devices

FDA 510(k) Submission Details - K981272

510(k) Number K981272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1998
Decision Date August 24, 1998
Days to Decision 139 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
10d slower than avg
Panel avg: 129d · This submission: 139d
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 57
Devices cleared under the same product code (MQX) and FDA review panel - the closest regulatory comparables to K981272.
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
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 NEEDLE, ACUPUNCTURE NEEDLE
K980472 · American Institute of Koryo Hand Therapy · Apr 1998