# K210227: Sterile syringe for single use with/without needle

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Kangkang Medical-Devices Co., Ltd.
- Decided: Sep 10, 2021 after 225 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.
2 later devices descend from it; 1 cites it directly.
0 of 25 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
- K213811: Sterile Hypodermic Syringes for Single Use (2022), 1 descendant of its own
- K252279: Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) (2026), 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/K210227
Methodology: https://510kreport.com/methodology