# K222656: LDE4 Lancing Device

- Pathway: 510(k) (Traditional)
- Applicant: I-Sens, Inc.
- Decided: Nov 23, 2022 after 82 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.
No later device cites it as a predicate yet.
0 of 4 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.

## Indications for use
LDE4 lancing device is used with a disposable blood lancet to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood.

Source page: https://510kreport.com/device/K222656
Methodology: https://510kreport.com/methodology