# K133493: Single Use Sterile Syringe with Needle

- Pathway: 510(k) (Abbreviated)
- Applicant: Jiangxi Kelun Medical Devices Manufacturing Co.,Lt
- Decided: Mar 27, 2014 after 133 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K022159 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111841: Shifeng Disposable Syringe with or Without Needle, Chengdu Xinjin Shifeng Med Appratus Inst Co., Ltd. (2012) Summary page 1.

## Indications for use
Single Use Sterile Syringe with Needle is intended to inject fluids into or withdraw fluid from, parts of the body below the surface of the skin.

Source page: https://510kreport.com/device/K133493
Methodology: https://510kreport.com/methodology