# K253622: Safety Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Medsun Medical Co., Ltd.
- Decided: Mar 18, 2026 after 120 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: 8 generations back to K970737 (1997). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210864: Safety Pen Needle, Sandstone Medical (Suzhou), Inc. (2022) Summary page 5.

## Indications for use
The Safety pen needle is intended for use with pen injector devices for subcutaneous injection of drugs. It has sharps protection feature of the patient-end and cartridge-end. For Model SD, the needle tube tip is 3 bevel. For Model SDW, the needle tube tip is 5 bevel.

Source page: https://510kreport.com/device/K253622
Methodology: https://510kreport.com/methodology