# K030190: Carbo/Optimed Brand Acupuncture Needles

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Sen Sen Medical Supplies, Ltd.
- Decided: Feb 21, 2003 after 31 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003760: Tai-Chi Acupuncture Needles, Lhasa Medical, Inc. (2001) Summary page 1.
- K981272: Addiquip Disposable Acupuncture Needles, Electro Therapeutic Devices, Inc. (1998) Summary page 1.

## Indications for use
This device is intended to pierce skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Source page: https://510kreport.com/device/K030190
Methodology: https://510kreport.com/methodology