# K092240: Acupuncture Needles

- Pathway: 510(k) (Traditional)
- Applicant: Haenglim Seowon Medical Co.
- Decided: Apr 21, 2010 after 272 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 K961339 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972659: Dong Bang Acupuncture Needles, Dong Bang, U.S.A. (1997) Summary page 1.
- K043277: C&G Acupuncture Needle, Helio Medical Supplies, Inc. (2005) Summary page 1.
- K052731: Kangsheng Brand/Kangnian Brand/Unilink Brand/Huazhong Brand Acupuncture Needles, Daxin LI (2006) Summary page 1.

## Indications for use
The device 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/K092240
Methodology: https://510kreport.com/methodology