# K132557: Ewnl Safety Syringe with Needle

- Pathway: 510(k) (Abbreviated)
- Applicant: Jiamei-Un Co., Ltd.
- Decided: Jun 3, 2014 after 293 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- 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 K000572 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022806: Duopro Safety Syringe (Duopross), M.K. Meditech Co., Ltd. (2002) Summary page 1.
- K034031: 10 ML Bak'snap Duopross Retractable Safety Syringe, M.K. Meditech Co., Ltd. (2004) Summary page 1.

## Indications for use
EWNLTM Safety Syringe with Needle (1 mL, 2 mL, 3 mL, 5 mL, and 10 mL) is a sterile, single-use, disposable and non-reusable manual retractable safety syringe, intended for medical purposes for injection of fluids into the body, while reducing the risks of sharps injuries and the potential for syringe reuse. This syringe is intended to be used by nurse, clinicians, or professional healthcare providers only.

Source page: https://510kreport.com/device/K132557
Methodology: https://510kreport.com/methodology