# K192082: Droplet Pen Needle 34G

- Pathway: 510(k) (Traditional)
- Applicant: Htl-Strefa S.A
- Decided: Apr 21, 2020 after 263 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.
2 later devices descend from it; 2 cite it directly.
0 of 10 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 5.

## Most influential descendants
- 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 DROPLET® PEN NEEDLE 34G is intended for use with pen injector devices for the subcutaneous injection of drugs.

Source page: https://510kreport.com/device/K192082
Methodology: https://510kreport.com/methodology