# K151949: Disposable Insulin Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Jiangyin Caina Technology Co., Ltd.
- Decided: Oct 2, 2015 after 79 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.
6 later devices descend from it; 1 cites it directly.
0 of 27 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 6.

## Most influential descendants
- K152808: U&U Insulin Syringe with/without Safety Retractable Device (2016), 5 descendants of its own
- K202570: Insulin Syringe, Insulin Syringe with Safety Retractable (2021), 2 descendants of its own
- K220061: Safety Insulin Syringes (2022), 1 descendant of its own
- K230061: Insulin Syringe (2023), 0 descendants of its own
- K191639: TK Insulin Syringe with/without Saftey Retractable Device (2020), 0 descendants of its own

## Indications for use
The disposable insulin syringe is 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.

Source page: https://510kreport.com/device/K151949
Methodology: https://510kreport.com/methodology