# K211482: Disposable Syringe with Needle

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Qinkai Medical Industry Co., Ltd.
- Decided: Jan 24, 2022 after 257 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: 5 generations back to K931367 (1993). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163161: Sterile Single-use Syringe with Needle, Jiangxi Hongda Medical Equipment Group, Ltd. (2017) Summary page 4.

## Indications for use
Sterile single-use syringe with needle is intended to inject fluids into or withdraw fluids from the body.

Source page: https://510kreport.com/device/K211482
Methodology: https://510kreport.com/methodology