# K222739: Disposable Insulin Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Hantech Medical Device Co., Ltd.
- Decided: Apr 6, 2023 after 209 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 K973899 (1997). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210059: Promisemed Insulin Pen Needle, Promisemed Hangzhou Meditech Co., Ltd. (2021) Summary page 4.

## Indications for use
The Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. It is sterile and for single use only. It can be used by the patient at home or healthcare professionals at medical/health care centers.

Source page: https://510kreport.com/device/K222739
Methodology: https://510kreport.com/methodology