# K974616: Singer Acupuncture Needles

- Pathway: 510(k) (Traditional)
- Applicant: Lorac, Inc.
- Decided: Feb 5, 1998 after 56 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 K962809 (1996). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962809: Seirin Acupuncture Needles, Seirin-America, Inc. (1996) Summary page 1.
- K962916: Hua-Xia Acupuncture Needles, Lhasa Medical, Inc. (1996) Summary page 1.

## Most influential descendants
- K090199: Jiajian Acupuncture Needle (2009), 0 descendants of its own

## 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/K974616
Methodology: https://510kreport.com/methodology