# K980472: KHT Soft Needle, Acupuncture Needle

- Pathway: 510(k) (Traditional)
- Applicant: American Institute of Koryo Hand Therapy
- Decided: Apr 9, 1998 after 62 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 K963769 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963769: Seirin Spinex Intradermal Acupuncture Needles, Seirin-America, Inc. (1996) 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/K980472
Methodology: https://510kreport.com/methodology