# K090910: Hanso Acupuncture Needle

- Pathway: 510(k) (Traditional)
- Applicant: Hansol Medical Co.
- Decided: Jun 30, 2009 after 90 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 K052085 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052085: Standard, Special, Special+, Sneedle B-Type and Sneedle J-Type Acupuncture Needles, Asia-Med GmbH and CO KG (2005) Summary page 1.

## Indications for use
An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.

Source page: https://510kreport.com/device/K090910
Methodology: https://510kreport.com/methodology