# K231729: Sterile syringes for single use with/without needle

- Pathway: 510(k) (Traditional)
- Applicant: Wepon Medical Technology Co., Ltd.
- Decided: Sep 8, 2023 after 87 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K931367 (1993). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112057: KDL Syringes and Needle, Shanghai Kindly Enterprise Dev. Group Co., (2011) Summary page 5.

## Indications for use
The Sterile syringes for single use with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

Source page: https://510kreport.com/device/K231729
Methodology: https://510kreport.com/methodology