# K210065: Verifine Safety Type Insulin Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Promisemed Hangzhou Meditech Co., Ltd.
- Decided: Apr 22, 2021 after 101 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.
No later device cites it as a predicate yet.
0 of 15 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.

## Indications for use
Verifine Safety Type Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. Additionally, after withdrawal of the Verifine 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/K210065
Methodology: https://510kreport.com/methodology