# K261719: Promisemed X-Safety Pen Needle

- Pathway: 510(k) (Special)
- Applicant: Promisemed Hangzhou Meditech Co., Ltd.
- Decided: Aug 25, 2026 after 91 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: 4 generations back to K051899 (2005). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220129: Promisemed X-Safety Pen Needle, Promisemed Hangzhou Meditech Co., Ltd. (2022) Summary page 5.

## Indications for use
Promisemed X-safety pen needle is intended for use with needle based injector for the injection of drugs.

Source page: https://510kreport.com/device/K261719
Methodology: https://510kreport.com/methodology