# K213013: Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Tech Co., Ltd.
- Decided: Sep 19, 2022 after 364 days
- Product code: QNQ (Low Dead Space Piston Syringe)
- 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: 8 generations back to K771205 (1977). 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)
- K192551: 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle, Jiangsu Caina Medical Co.,Ltd (2020) Summary page 4.

## Indications for use
STERILE SINGLE USE LDV SYRINGE/CHOICARE STERILE SINGLE USE LDV SYRINGE is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.

Source page: https://510kreport.com/device/K213013
Methodology: https://510kreport.com/methodology