# K222472: Lancing System, Sterile Lancet for Single Use, Lancing Device

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Lianfa Medical Plastic Products Co., Ltd.
- Decided: Nov 30, 2022 after 106 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K810075 (1981). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K214022: Accu-Chek Softclix Blood Lancing System, Roche Diabetes Care, Inc. (2022) Summary page 5.

## Recalls of this device
- Jul 25, 2025 · Class III · Z-0226-2026: Due to incorrect/lack of Unique Device Identifier (UDI) codes.

## Indications for use
“Lancing System” consists of “Sterile Lancet for Single Use” and “Lancing Device” The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm. The reusable lancing device is to be used with sterile, single-use lancets, and is to be cleaned and disinfected between each use, and then the lancets are to be disposed of. The lancing device is for use only on a single patient in a home setting. This lancing device is not suitable for use by healthcare professionals with multiple patients in a healthcare setting. “Sterile Lancet for Single Use” is a single use device indicated for capillary blood sampling. It can be used in conjunction with “Lancing Device” in home settings, or be used standalone in both home and hospital settings.

Source page: https://510kreport.com/device/K222472
Methodology: https://510kreport.com/methodology