# K232488: Accu-Chek Safe-T-Pro Plus Lancing Device

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diabetes Care, Inc.
- Decided: Nov 13, 2023 after 88 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: 3 generations back to K822209 (1982). 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)
- K220849: Accu-Chek Safe-T-Pro Plus Lancing Device, Roche Diabetes Care, Inc. (2022) Summary page 4.

## Indications for use
The Accu-Chek Safe-T-Pro Plus lancing device is intended to produce a capillary blood sample for testing utilizing small amounts of blood.

Source page: https://510kreport.com/device/K232488
Methodology: https://510kreport.com/methodology