# K221178: Disposable Insulin Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Medsun Medical Co., Ltd.
- Decided: Nov 17, 2022 after 206 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: 9 generations back to K970737 (1997). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170846: Disposable Insulin Pen Needle, Jiangsu Caina Technology Co., Ltd. (2017) Summary page 4.
- K192677: Safety Insulin Pen Needle, Jiangsu Caina Medical Co.,Ltd (2020) Summary page 4.

## Indications for use
Disposable Insulin Pen Needle(Model CT) : Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. Disposable Insulin Pen Needle(Model ST) : Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. Additionally, it has sharps injury protection feature that it can reduce the occurrence of accidental needlesticks from the patient end of the needle due to the effect of safe-lock guard.

Source page: https://510kreport.com/device/K221178
Methodology: https://510kreport.com/methodology