# K202319: Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)

- Pathway: 510(k) (Traditional)
- Applicant: Tianjin Huahong Technology Co., Ltd.
- Decided: Nov 12, 2021 after 452 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). 10 ancestors in all.
1 later device descends from it; 1 cites 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)
- K181069: Disposable Insulin Pen Needle, Zhejiang Kindly Medical Devices Co., Ltd. (2018) Summary page 4.
- K170988: DropSafe Safety Pen Needle, Htl-Strefa S.A (2017) Summary page 4.

## Most influential descendants
- K230043: Insulin Pen Needle (2023), 0 descendants of its own

## Indications for use
The Insulin Pen Needle (Ordinary Type) is intended for use with pen injector devices for the subcutaneous injection of insulin. The Insulin Pen Needle (Safety Type) is sterile, single-use safety needle intended for use with pen injector devices for the subcutaneous injection of insulin.

Source page: https://510kreport.com/device/K202319
Methodology: https://510kreport.com/methodology