# K111392: Woojeon Acupuncture Needle (=Sera Acupuncture Needle)

- Pathway: 510(k) (Traditional)
- Applicant: Woojeon Company
- Decided: Nov 4, 2011 after 170 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: 1 generation back to K052085 (2005). 1 ancestor in all.
2 later devices descend 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)
- K052085: Standard, Special, Special+, Sneedle B-Type and Sneedle J-Type Acupuncture Needles, Asia-Med GmbH and CO KG (2005) Summary page 1.

## Most influential descendants
- K141473: SMC Acupuncture Needle (2014), 1 descendant of its own
- K162566: AIK Sterile Acupuncture Needles for Single Use (2017), 0 descendants of its own

## Indications for use
WOOJEON ACUPUNCTURE NEEDLES 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/K111392
Methodology: https://510kreport.com/methodology