# K251089: EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle

- Pathway: 510(k) (Traditional)
- Applicant: Exelint International, Co.
- Decided: Dec 12, 2025 after 246 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: 10 generations back to K771205 (1977). 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)
- K232950: Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle, Perfect Medical Industry (Vn) Co., Ltd. (2024) Summary page 5.

## Indications for use
These devices are intended to be used: - to inject fluids into, or withdraw fluids from, the body. - to administer and/or withdraw (aspirate) fluids/drugs. These devices are intended for use by qualified healthcare professionals in a professional healthcare environment. These devices are intended for use in the general population, including both adult and pediatric patients of all age groups, as determined appropriate by the qualified healthcare professional using the device.

Source page: https://510kreport.com/device/K251089
Methodology: https://510kreport.com/methodology