# K213183: Safety Insulin Pen Needles

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Kindly Medical Devices Co., Ltd.
- Decided: Oct 14, 2022 after 380 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: 8 generations back to K970737 (1997). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181447: Safety insulin needle for single use, Berpu Medical Technology Co., Ltd. (2019) Summary page 4.

## Indications for use
Safety Insulin Pen Needle is intended to be used with Insulin Pen for hypodermic injection of insulin and medicinal fluids.

Source page: https://510kreport.com/device/K213183
Methodology: https://510kreport.com/methodology