# K221045: Insulin Syringes without needle

- Pathway: 510(k) (Traditional)
- Applicant: Berpu Medical Technology Co., Ltd.
- Decided: Nov 3, 2022 after 209 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.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162180: Disposable Insulin Syringe, Berpu Medical Technology Co., Ltd. (2016) Summary page 4.

## Indications for use
The Insulin Syringes without needle is intended for medical purpose in conjunction with sterile needle for the manual aspiration and injection of U100 insulin into subcutaneous tissues.

Source page: https://510kreport.com/device/K221045
Methodology: https://510kreport.com/methodology