# K110421: Disposable Insulin Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Wenzhou Wuzhou Import & Export Co., Ltd.
- Decided: Apr 26, 2011 after 71 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: 4 generations back to K931367 (1993). 20 ancestors in all.
36 later devices descend from it; 3 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072739: Jierui Syringes and Needles, Shandong Weigao Group Medical Polymer Co., Ltd. (2008) Summary page 2.

## Most influential descendants
- K112057: KDL Syringes and Needle (2011), 31 descendants of its own
- K190002: Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use (2019), 13 descendants of its own
- K153537: Sol-M  Insulin Syringe, Sol-M TB Syringe (2016), 5 descendants of its own
- K170218: Vesco Medical NRFit Tip Syringes (2017), 4 descendants of its own
- K211242: Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes (2021), 3 descendants of its own

## Indications for use
Disposable insulin syringe is a device intended for medical purpose for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.

Source page: https://510kreport.com/device/K110421
Methodology: https://510kreport.com/methodology