# K170846: Disposable Insulin Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Caina Technology Co., Ltd.
- Decided: Dec 13, 2017 after 267 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 K973899 (1997). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152824: Medt Pen Needle, Shandong Caremed Medical Products Co., Ltd. (2016) Summary page 5.

## Most influential descendants
- K221178: Disposable 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/K170846
Methodology: https://510kreport.com/methodology