# K143437: Droplet Pen Needles

- Pathway: 510(k) (Traditional)
- Applicant: Htl-Strefa S.A
- Decided: Jun 25, 2015 after 206 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: 2 generations back to K051899 (2005). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031200: Modification to BD Ultra-Fine Iii Pen Needle, Becton, Dickinson & CO (2003) Summary page 4.
- K100005: BD Pen Needle, Becton, Dickinson and Co. (2010) Summary page 4.

## Most influential descendants
- K171982: Droplet Pen Needle (2018), 3 descendants of its own
- 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
The Droplet® Pen Needles are intended for use with pen injector device for the subcutaneous injection of insulin.

Source page: https://510kreport.com/device/K143437
Methodology: https://510kreport.com/methodology