# K962809: Seirin Acupuncture Needles

- Pathway: 510(k) (Traditional)
- Applicant: Seirin-America, Inc.
- Decided: Aug 16, 1996 after 29 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
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Acupuncture needles in commercial distribution prior to May 28, 1976: named in the summary without a submission number
- (no number) Other acupuncture needles currently sold through interstate commerce: named in the summary without a submission number

## Most influential descendants
- K974616: Singer Acupuncture Needles (1998), 1 descendant of its own
- K090199: Jiajian Acupuncture Needle (2009), 0 descendants of its own
- K031060: Nano Tech and Super Nano Acupuncture Needles (2003), 0 descendants of its own
- K023787: Tai-Chi and Master Acupuncture Needles (2003), 0 descendants of its own
- K980899: Jin Acupuncture Needles, Models ST, GL, SI, PT, and ID (1998), 0 descendants of its own

## Indications for use
Acupuncture needles are defined as devices 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/K962809
Methodology: https://510kreport.com/methodology