# K220129: Promisemed X-Safety Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Promisemed Hangzhou Meditech Co., Ltd.
- Decided: Sep 19, 2022 after 244 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: 3 generations back to K051899 (2005). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163578: EasyTouch Safety Pen Needle, Mhc Medical Products, LLC (2018) Summary page 4.

## Most influential descendants
- K252886: Pen Needle (2026), 1 descendant of its own
- K261719: Promisemed X-Safety Pen Needle (2026), 0 descendants of its own
- K262427: Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII) (2026), 0 descendants of its own

## 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/K220129
Methodology: https://510kreport.com/methodology