# K171982: Droplet Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Htl-Strefa S.A
- Decided: Mar 21, 2018 after 264 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: 5 generations back to K051899 (2005). 7 ancestors in all.
3 later devices descend from it; 3 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)
- K162516: BD Pen Needle, Becton, Dickinson and Company (2016) Summary page 5.
- K143437: Droplet Pen Needles, Htl-Strefa S.A (2015) Summary page 5.

## Most influential descendants
- K260739: Profoject™ Pen Needles (Model A; Model B) (2026), 0 descendants of its own
- K230635: Pen Needle (2023), 0 descendants of its own
- K192464: Injection Pen Needle (2020), 0 descendants of its own

## Indications for use
Droplet® Pen Needles are intended for use with pen injector devices for the subcutaneous injection of drugs.

Source page: https://510kreport.com/device/K171982
Methodology: https://510kreport.com/methodology