Cleared Traditional

K011242 - HUANQIU AND SUPER (TWO BRANDS) STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE

K011242 is an FDA 510(k) clearance for HUANQIU AND SUPER (TWO BRANDS) STERILE ..., manufactured by Acusupply, Inc.. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K011242 · Acusupply, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
141d
Days
Class 2
Risk

K011242 is an FDA 510(k) clearance for the HUANQIU AND SUPER (TWO BRANDS) STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Acusupply, Inc. (Aventura, US). The FDA issued a Cleared decision on September 11, 2001 after a review of 141 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 Acusupply, Inc. devices

FDA 510(k) Submission Details - K011242

510(k) Number K011242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2001
Decision Date September 11, 2001
Days to Decision 141 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 129d · This submission: 141d
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 44
Devices cleared under the same product code (MQX) and FDA review panel - the closest regulatory comparables to K011242.
SMC ACUPUNCTURE NEEDLE
K141473 · Smc Intl., Inc. · Aug 2014
CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE
K132896 · Asia-Med GmbH and CO KG · Dec 2013
WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE)
K111392 · Woojeon Company · Nov 2011
SEDATELEC ASP ACUPUNCTURE NEEDLES
K983798 · Sedatelec · Aug 1999
DN ACUPUNTURE NEEDLES
K983800 · Sedatelec · Aug 1999
KANGNIAN BRAND ACUPUNCTURE NEEDLE
K991507 · Helio Medical Supplies, Inc. · Aug 1999