# K250700: Pen Injector Needle 32.5

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Corporation
- Decided: Nov 21, 2025 after 259 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140516: Terumo Pen Injector Needle 34, Kofu Factory of Terumo Corp. (2014) Summary page 6.

## Indications for use
The Pen Injector Needle 32.5 is indicated for use with a pen injector device for patients who require the subcutaneous injection of drugs including insulin and human growth hormone as a therapy.

Source page: https://510kreport.com/device/K250700
Methodology: https://510kreport.com/methodology