# K210991: Disposable Sterile Syringe, Disposable Sterile Syringe with Needle

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Antmed Co., Ltd.
- Decided: Aug 26, 2021 after 146 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: 4 generations back to K931367 (1993). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072739: Jierui Syringes and Needles, Shandong Weigao Group Medical Polymer Co., Ltd. (2008) Summary page 4.

## Indications for use
The Disposable Sterile Syringe with Needle is intended for use in the aspiration and injection of fluids for medical purpose. The Disposable Sterile Syringe is a sterile luer lock syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.

Source page: https://510kreport.com/device/K210991
Methodology: https://510kreport.com/methodology