# K242632: Verifine® Pen Needles

- Pathway: 510(k) (Special)
- Applicant: Promisemed Hangzhou Meditech Co., Ltd.
- Decided: Sep 26, 2024 after 23 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 5.

## Indications for use
Verifine® Pen Needle is intended for use with pen injector device for the subcutaneous injection of drugs.

Source page: https://510kreport.com/device/K242632
Methodology: https://510kreport.com/methodology