# K223643: Verifine® Ease Lancing Device, Verifine® Lancing Device

- Pathway: 510(k) (Traditional)
- Applicant: Promisemed Hangzhou Meditech Co., Ltd.
- Decided: Feb 21, 2023 after 77 days
- Product code: QRL (Multiple Use Blood Lancet For Single Patient Use Only)
- 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 K002134 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153670: Genteel Lancing Device, Genteel, LLC (2016) Summary page 4.

## Indications for use
It is intended to be used with disposable sterile lancets to collect capillary blood from the fingertip or alternate sites for blood glucose testing or other testing utilizing small amounts of blood. It is for single patient use only.

Source page: https://510kreport.com/device/K223643
Methodology: https://510kreport.com/methodology