# K220849: Accu-Chek Safe-T-Pro Plus Lancing Device

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diabetes Care, Inc.
- Decided: May 19, 2022 after 57 days
- Product code: FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature)
- 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 K822209 (1982). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101145: Surgilance Safety Lancets, Models SLN100, SLN200, SLN240, SLN300, SLB200, SLB250, Medipurpose Pte., Ltd. (2010) Summary page 4.

## Most influential descendants
- K232488: Accu-Chek Safe-T-Pro Plus Lancing Device (2023), 0 descendants of its own

## Indications for use
The Accu-Chek Safe-T-Pro Plus lancing device is a sterile, single-use, disposable lancing device intended to be used by healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel.

Source page: https://510kreport.com/device/K220849
Methodology: https://510kreport.com/methodology