# K021095: Holy Dragon Brand Acupuncture Needles

- Pathway: 510(k) (Traditional)
- Applicant: Wujiang City Hua Xin Medical Appliance Co., Ltd.
- Decided: May 17, 2002 after 43 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 K002910 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002910: Holy Dragon Acupuncture Needles, Anc Import & Export Co., Ltd. (2001) Summary page 1.
- K011247: Holy Dragon Sterile Acupuncture Needle for Single Use, Acusupply, Inc. (2001) Summary page 1.

## Indications for use
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/K021095
Methodology: https://510kreport.com/methodology