# K161950: Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Promisemed Hangzhou Meditech Co., Ltd.
- Decided: May 11, 2017 after 300 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: 6 generations back to K973899 (1997). 13 ancestors in all.
9 later devices descend from it; 6 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133059: Insulin Pen Needle, Wenzhou Beipu Science & Technology Co., Ltd. (2014) Summary page 5.
- K151311: Safe Block Pen Needle, Artsana S.P.A (2016) Summary page 5.

## Most influential descendants
- K210059: Promisemed Insulin Pen Needle (2021), 1 descendant of its own
- K193422: Easydrip Pen Needle, Easydrip Plus Pen Needle (2021), 1 descendant of its own
- K191853: Dual-Safety Pen Needle (2019), 1 descendant of its own
- K252908: Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle (2026), 0 descendants of its own
- K242632: Verifine® Pen Needles (2024), 0 descendants of its own

## Indications for use
The Common Type Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. The Safety Type Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. Additionally, after withdrawal of the Safety Type Insulin Pen Needle from the body, the attached needle safety shield automatically covers the needle to minimize the risk of accidental needlestick.

Source page: https://510kreport.com/device/K161950
Methodology: https://510kreport.com/methodology