# K210200: 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock

- Pathway: 510(k) (Special)
- Applicant: Set Medikal Sanayi VE Ticaret Anonim Sirketi
- Decided: May 14, 2021 after 109 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 K931367 (1993). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201284: Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use, Set Medikal Sanayi VE Ticaret Anonim Sirketi (2020) Summary page 4.

## Indications for use
The Sterile Hypodermic Syringe for Single Use with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

Source page: https://510kreport.com/device/K210200
Methodology: https://510kreport.com/methodology