# K221970: Lancing device

- Pathway: 510(k) (Traditional)
- Applicant: SteriLance Medical (Suzhou), Inc.
- Decided: Aug 30, 2022 after 56 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: 3 generations back to K002134 (2000). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113332: ON Call Chosen Lancing Device, ACON Laboratories, Inc. (2012) Summary page 5.

## Most influential descendants
- K260122: Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) (2026), 0 descendants of its own
- K250813: MICROLET®NEXT 2 Lancing Device (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/K221970
Methodology: https://510kreport.com/methodology