# K980469: KHT Sooji Needle, Hand Acupuncture Needle

- Pathway: 510(k) (Traditional)
- Applicant: American Institute of Koryo Hand Therapy
- Decided: Apr 3, 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K862419: Serum Vancomycin Toxicology Control, Utak Laboratories, Inc. (1986). Our OCR of the scanned summary read K862419, FDA’s number for Serum Vancomycin Toxicology Control (Utak Laboratories, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “CW-Disposable Acupuncture Needle”. Kept off the family tree. Summary page 1.

## 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/K980469
Methodology: https://510kreport.com/methodology