# K141473: SMC Acupuncture Needle

- Pathway: 510(k) (Traditional)
- Applicant: Smc Intl., Inc.
- Decided: Aug 1, 2014 after 59 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: 2 generations back to K052085 (2005). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111392: Woojeon Acupuncture Needle (=Sera Acupuncture Needle), Woojeon Company (2011) Summary page 5.

## Most influential descendants
- K162566: AIK Sterile Acupuncture Needles for Single Use (2017), 0 descendants of its own

## Indications for use
SMC ACUPUNCTURE NEEDLE 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/K141473
Methodology: https://510kreport.com/methodology