# K112057: KDL Syringes and Needle

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Kindly Enterprise Dev. Group Co.,
- Decided: Dec 14, 2011 after 148 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: 5 generations back to K931367 (1993). 21 ancestors in all.
31 later devices descend from it; 6 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070936: Welmed Hypodermic Syringe, Welmed, Inc. (2007) Summary page 5.
- K072739: Jierui Syringes and Needles, Shandong Weigao Group Medical Polymer Co., Ltd. (2008) Summary page 2.
- K110421: Disposable Insulin Syringe, Wenzhou Wuzhou Import & Export Co., Ltd. (2011) Summary page 2.
- K070440: BD Hypoint Needle, Becton, Dickinson & CO (2007) Summary page 2.

## Most influential descendants
- 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
- K212635: Sofjec (2023), 2 descendants of its own

## 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. The sterile insulin syringe for single use with needle, with the calibration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin. The sterile insulin syringe for single use with needle, with the calibration unit of insulin for U-40, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin. The sterile hypodermic needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

Source page: https://510kreport.com/device/K112057
Methodology: https://510kreport.com/methodology