# K142920: KM Needles (Acupuncture Needle)

- Pathway: 510(k) (Traditional)
- Applicant: K.M.S., Inc.
- Decided: Jun 10, 2015 after 245 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 K972659 (1997). 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)
- K972659: Dong Bang Acupuncture Needles, Dong Bang, U.S.A. (1997) Summary page 4.

## Indications for use
This KM Needles (Acupuncture Needle) is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the state regulations.

Source page: https://510kreport.com/device/K142920
Methodology: https://510kreport.com/methodology