# K162566: AIK Sterile Acupuncture Needles for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Changchun Aik Medical Devices Co., Ltd.
- Decided: May 11, 2017 after 239 days
- Product code: MQX (Needle, Acupuncture, Single Use)
- Device class: 2
- Regulation: 21 CFR 880.5580
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K052085 (2005). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141473: SMC Acupuncture Needle, Smc Intl., Inc. (2014) Summary page 5.

## Indications for use
The AIK Sterile Acupuncture Needles for Single Use is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Source page: https://510kreport.com/device/K162566
Methodology: https://510kreport.com/methodology