# K142760: Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles

- Pathway: 510(k) (Traditional)
- Applicant: K.S. Choi Corporation
- Decided: Aug 25, 2015 after 334 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 K031716 (2003). 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)
- K031716: Special+, S-Needle J-Type, S-Needle B-Type, Asia-Med GmbH and CO KG (2003) Summary page 4.
- K042063: Press Tack Needle, Asia-Med GmbH & Co. Kg. - Werk Suhl (2004) Summary page 4.

## Indications for use
Our acupuncture needles are devices used by licensed practitioners and are 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/K142760
Methodology: https://510kreport.com/methodology