# K162180: Disposable Insulin Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Berpu Medical Technology Co., Ltd.
- Decided: Dec 29, 2016 after 147 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.
5 later devices descend from it; 3 cite it directly.
0 of 26 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 5.

## Most influential descendants
- K193273: Insulin Syringe (2021), 2 descendants of its own
- K222672: Disposable Insulin Syringe (2023), 0 descendants of its own
- K203211: Insulin syringe with integrated needle DL (2023), 0 descendants of its own
- K221045: Insulin Syringes without needle (2022), 0 descendants of its own
- K210712: Verifine Mechanical Safety Insulin Syringe (2021), 0 descendants of its own

## Indications for use
The disposable insulin syringe is intended for medical purposes for the manual aspiration of U-100 insulin, and for the injection of insulin into parts of the body below the surface skin.

Source page: https://510kreport.com/device/K162180
Methodology: https://510kreport.com/methodology