# K211211: Sterile syringes for single use with/without needle

- Pathway: 510(k) (Traditional)
- Applicant: Azur Medical Company, Inc.
- Decided: Oct 7, 2021 after 167 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: 6 generations back to K931367 (1993). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112057: KDL Syringes and Needle, Shanghai Kindly Enterprise Dev. Group Co., (2011) Summary page 4.

## Most influential descendants
- K252033: Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle (2025), 0 descendants of its own

## Indications for use
The Sterile syringes for single use with/without needle are intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

Source page: https://510kreport.com/device/K211211
Methodology: https://510kreport.com/methodology