# K212518: Jeesung Safety Syringe and Single Use Needles

- Pathway: 510(k) (Special)
- Applicant: Jeesung Medical Co., Ltd.
- Decided: Aug 18, 2022 after 373 days
- Product code: MEG (Syringe, Antistick)
- 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 K040545 (2004). 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)
- K152606: Jeesung Safety Syringe and Single Use Needles, Jeesung Medical Co., Ltd. (2016) Summary page 4.

## Indications for use
Jeesung safety syringe and single use needles is a sterile, single-use, disposable and non-reusable, manual retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.

Source page: https://510kreport.com/device/K212518
Methodology: https://510kreport.com/methodology