# K970254: Seirin Pyonex Acupuncture Needles

- Pathway: 510(k) (Traditional)
- Applicant: Seirin-America, Inc.
- Decided: Feb 10, 1997 after 19 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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 which were in commercial distribution prior to May 28, 1976: named in the summary without a submission number
- (no number) Other acupuncture needles which are currently being sold through interstate commerce: named in the summary without a submission number

## Most influential descendants
- K031250: DBC Press Acupuncture Needles (2003), 0 descendants of its own
- K983798: Sedatelec Asp Acupuncture Needles (1999), 0 descendants of its own

## Indications for use
Pyonex 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/K970254
Methodology: https://510kreport.com/methodology