# K181069: Disposable Insulin Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Kindly Medical Devices Co., Ltd.
- Decided: Aug 28, 2018 after 127 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: 6 generations back to K973899 (1997). 8 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133059: Insulin Pen Needle, Wenzhou Beipu Science & Technology Co., Ltd. (2014) Summary page 5.

## Most influential descendants
- K202319: Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) (2021), 1 descendant of its own
- K230043: Insulin Pen Needle (2023), 0 descendants of its own
- K221176: Insulin Pen Needle (2022), 0 descendants of its own

## Indications for use
The Disposable Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.

Source page: https://510kreport.com/device/K181069
Methodology: https://510kreport.com/methodology