# K260122: Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)

- Pathway: 510(k) (Traditional)
- Applicant: SteriLance Medical (Suzhou), Inc.
- Decided: Jul 6, 2026 after 172 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)
- K221970: Lancing device, SteriLance Medical (Suzhou), Inc. (2022) Summary page 5.

## Indications for use
Lancing device is used with disposable blood lancet to obtain capillary blood samples.

Source page: https://510kreport.com/device/K260122
Methodology: https://510kreport.com/methodology