# K181447: Safety insulin needle for single use

- Pathway: 510(k) (Traditional)
- Applicant: Berpu Medical Technology Co., Ltd.
- Decided: Mar 12, 2019 after 284 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K970737 (1997). 10 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152514: Clickfine AutoProtect Pen Needle, Ypsomed AG (2015) Summary page 5.

## Most influential descendants
- K192677: Safety Insulin Pen Needle (2020), 1 descendant of its own
- K221178: Disposable Insulin Pen Needle (2022), 0 descendants of its own
- K213183: Safety Insulin Pen Needles (2022), 0 descendants of its own
- K212514: Safety Pen Needle for Single Use, Insulin Pen Needles (2022), 0 descendants of its own

## Indications for use
The safety insulin needle for single use is intended for use with pen injector devices for the subcutaneous injection of insulin.

Source page: https://510kreport.com/device/K181447
Methodology: https://510kreport.com/methodology