MQXClass II

Needle, Acupuncture, Single Use

21 CFR 880.5580 / General Hospital

MQX is the FDA product code for Needle, Acupuncture, Single Use, a class II device type, regulated under 21 CFR 880.5580. As of 2026-09-10, FDA records hold 91 510(k) clearances under this code, the most recent dated 2017-05-11, and one recall.

Classification record

Product code: MQX
Device name: Needle, Acupuncture, Single Use
Regulation: 21 CFR 880.5580
Device class: Class II
Review panel: General Hospital
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 91
Ingested recalls: 1

Clearances, product code MQX

By decision year

91 clearances under product code MQX with a decision year between 1996 and 2017, 1996 the highest year at 13.

Show the numbers

510(k) clearances under FDA product code MQX by decision year
Year	Clearances
1996	13
1997	7
1998	9
1999	8
2000	5
2001	12
2002	5
2003	7
2004	2
2005	5
2006	5
2007	1
2008	1
2009	2
2010	1
2011	2
2013	1
2014	1
2015	3
2017	1

Applicants with the most clearances

Product code MQX

Applicants holding the most 510(k) clearances under product code MQX
Applicant	Clearances
Helio Medical Supplies, Inc.	10
Lhasa Medical, Inc.	9
American Institute of Koryo Hand Therapy	5
Asia-Med GmbH and CO KG	4
Seirin-America, Inc.	4
Acusupply, Inc.	3
Sedatelec	3
united pacific Company	3
Acupuncture Supplies Import Co.	2
C.A.I. Industries Corp.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 72 companies shown, in name order