# K210059: Promisemed Insulin Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Promisemed Hangzhou Meditech Co., Ltd.
- Decided: Jul 21, 2021 after 191 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). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161950: Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle, Promisemed Hangzhou Meditech Co., Ltd. (2017) Summary page 4.

## Most influential descendants
- K222739: Disposable Insulin Pen Needle (2023), 0 descendants of its own

## Indications for use
Promisemed 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 is suitable for all age groups including neonate, infant, children and adult, and can be used by the patient at home or healthcare professionals at medical/health care centers.

Source page: https://510kreport.com/device/K210059
Methodology: https://510kreport.com/methodology