# K023054: Jia Chen Acupuncture Needle, for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Mandala Health Care, LLC
- Decided: Nov 13, 2002 after 61 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 K991507 (1999). 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)
- K991507: Kangnian Brand Acupuncture Needle, Helio Medical Supplies, Inc. (1999) Summary page 1.
- K003010: Spirit Acupuncture Needle, United Pacific Co., Ltd. (2000)
- K002411: Shenling Acupuncture Needles, Shenling Medical Device Co., Ltd. (2000)

## Indications for use
Jia Chen Acupuncture Needie will be used for “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/K023054
Methodology: https://510kreport.com/methodology