# K252886: Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Hh Global Technology, Inc.
- Decided: Jan 6, 2026 after 118 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.
1 later device descends from it; 1 cites it directly.
0 of 6 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.

## Most influential descendants
- 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
Pen Needles are sterile, single use needles intended for using with pen injector devices for the injection of drug.

Source page: https://510kreport.com/device/K252886
Methodology: https://510kreport.com/methodology