# K140516: Terumo Pen Injector Needle 34

- Pathway: 510(k) (Traditional)
- Applicant: Kofu Factory of Terumo Corp.
- Decided: Aug 5, 2014 after 158 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). 6 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123300: BD Pen Needle, Becton, Dickinson & CO (2013) Summary page 7.
- K052561: Terumo Micro Tapered Pen Needle, Kofu Factory of Terumo Corp. (2005) Summary page 7.

## Most influential descendants
- K192082: Droplet Pen Needle 34G (2020), 2 descendants of its own
- K250700: Pen Injector Needle 32.5 (2025), 0 descendants of its own
- K203792: Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle (2023), 0 descendants of its own
- K202340: Droplet Pen Needle 30G & 33G (2020), 0 descendants of its own

## Indications for use
The Terumo® Pen Injector Needle 34 is intended for use with a pen injector device for the subcutaneous injection of drugs, including insulin.

Source page: https://510kreport.com/device/K140516
Methodology: https://510kreport.com/methodology