# K192677: Safety Insulin Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Caina Medical Co.,Ltd
- Decided: Feb 18, 2020 after 145 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.
1 later device descends from it; 1 cites it directly.
0 of 13 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 5.

## Most influential descendants
- K221178: Disposable Insulin Pen Needle (2022), 0 descendants of its own

## Indications for use
The Safety Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin. The attached safety shield automatically locks after injection and reduces the occurrence of accidental needle sticks from the patient end of the needle.

Source page: https://510kreport.com/device/K192677
Methodology: https://510kreport.com/methodology