# K213054: Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Dec 9, 2022 after 443 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: 8 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)
- K193526: Syringe with safety needle, Safety needle, Jiangsu Caina Medical Co.,Ltd (2020) Summary page 4.
- K161170: BD Eclipse Hypodermic Needle, Becton, Dickinson and Company (2016) Summary page 4.

## Indications for use
The Medline Sure-Snap Safety Syringe is intended for use in the aspiration and injection of fluids for medical purposes. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick. The Medline Sure-Snap Safety Needle is intended for use with a luer-lock syringe for aspiration and injection of fluids for medical purposes. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick.

Source page: https://510kreport.com/device/K213054
Methodology: https://510kreport.com/methodology