# K250016: droplet® personal lancets

- Pathway: 510(k) (Traditional)
- Applicant: Htl-Strefa S.A
- Decided: Jul 1, 2025 after 179 days
- Product code: QRK (Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature)
- Device class: 2
- Regulation: 21 CFR 878.4850
- 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 K822209 (1982). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221507: Disposable Blood Lancet, SteriLance Medical (Suzhou), Inc. (2022) Summary page 6.

## Indications for use
droplet® personal lancets are sterile, single-use medical devices intended to be used with a lancing device by lay users for capillary blood sampling.

Source page: https://510kreport.com/device/K250016
Methodology: https://510kreport.com/methodology