FDA product code MQX: Needle, Acupuncture, Single Use
MQX is the FDA product code for needle, acupuncture, single use. It is a Class II device, regulated under 21 CFR 880.5580 and reviewed by the General Hospital panel. FDA has cleared 91 510(k) submissions under MQX, from 52 different applicants. The average 510(k) review took 106 days (median 83). FDA has posted 1 recall for MQX devices.
Classification
| Field | Value |
|---|---|
| Device name | Needle, Acupuncture, Single Use |
| Device class | Class II |
| Regulation | 21 CFR 880.5580 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
510(k) clearances per year for MQX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 239 |
Compare with all 510(k) review times · Search every MQX clearance
Top MQX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Helio Medical Supplies, Inc. | 10 | 2007-11-19 |
| Lhasa Medical, Inc. | 9 | 2003-07-15 |
| American Institute of Koryo Hand Therapy | 5 | 1998-04-09 |
| Asia-Med GmbH and CO KG | 4 | 2013-12-02 |
| Seirin-America, Inc. | 4 | 1997-02-10 |
47 more applicants have MQX clearances. See the full list in Caduvo.
Most recent MQX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K162566 | Changchun Aik Medical Devices Co., Ltd. | AIK Sterile Acupuncture Needles for Single Use | 2017-05-11 | 239 |
| K142760 | K.S. Choi Corporation | Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles | 2015-08-25 | 334 |
| K150903 | Maanshan Bond Medical Instruments Co., Ltd. | EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural | 2015-07-15 | 103 |
| K142920 | K.M.S., Inc. | KM Needles (Acupuncture Needle) | 2015-06-10 | 245 |
| K141473 | Smc Intl., Inc. | SMC ACUPUNCTURE NEEDLE | 2014-08-01 | 59 |
Recalls for MQX devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2007-11-28.
Frequently asked questions
What is FDA product code MQX?
MQX is the FDA product code for needle, acupuncture, single use. It is a Class II device, regulated under 21 CFR 880.5580 and reviewed by the General Hospital panel.
What device class is MQX?
Class II, regulation 21 CFR 880.5580. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MQX?
Across 91 cleared submissions the average was 106 days from receipt to decision (median 83).
Which companies have the most MQX 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).
Have MQX devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2007-11-28.
Next steps
- Run an FDA pathway report with predicate devices for product code MQX
- Run a recall and safety report across every MQX manufacturer
- Watch product code MQX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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