# K221613: Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets

- Pathway: 510(k) (Traditional)
- Applicant: Owen Mumford, Ltd.
- Decided: Oct 3, 2022 after 122 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: 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.

## Indications for use
Freestyle Lancing Device II: Use with compatible lancets for capillary blood sampling. Autolet: Use with compatible lancets for capillary blood sampling. Autolet Lite: Use with compatible lancets for capillary blood sampling. Unilet Lancets: Use with compatible lancing device for capillary blood sampling.

Source page: https://510kreport.com/device/K221613
Methodology: https://510kreport.com/methodology