# K221072: TRUEdraw Lancing Device, Mini Lancing Device

- Pathway: 510(k) (Traditional)
- Applicant: Trividia Health
- Decided: Oct 18, 2022 after 189 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 4.

## Indications for use
The TRUEdraw Lancing Device is for use with a disposable sterile lancet for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the forearm. The Mini Lancing Device is for use with a disposable sterile lancet for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the forearm. The TRUEdraw Lancing Device/ Mini Lancing Device is for use only on a single patient in a home setting. The TRUEdraw Lancing Device/ Mini Lancing Device is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

Source page: https://510kreport.com/device/K221072
Methodology: https://510kreport.com/methodology