# K214022: Accu-Chek Softclix Blood Lancing System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diabetes Care, Inc.
- Decided: Feb 17, 2022 after 57 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: 1 generation back to K810075 (1981). 1 ancestor in all.
12 later devices descend from it; 12 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K810075: Autoclix, Biodynamics Corp. (1981) Summary page 4.

## Most influential descendants
- K230712: SG Lanset I, SG Lancets, Soft Lancets (2023), 0 descendants of its own
- K230310: STAT Medical Device Lancing System (2023), 0 descendants of its own
- K222617: EasyTouch Lancing Device (2023), 0 descendants of its own
- K223815: ONE DROP Lancing Device (2023), 0 descendants of its own
- K221419: TD-5010 Lancing Device and TD-5084 Sterile Lancets (2023), 0 descendants of its own

## Indications for use
The Accu-Chek Softclix Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm. The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of. This system is for use only on a single patient in a home setting. This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

Source page: https://510kreport.com/device/K214022
Methodology: https://510kreport.com/methodology