# K230712: SG Lanset I, SG Lancets, Soft Lancets

- Pathway: 510(k) (Traditional)
- Applicant: Sewon Medical Co.
- Decided: Dec 6, 2023 after 266 days
- Product code: QRK (Single Use Only Blood Lancet Without 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 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
The SG LANSET I, SG LANCETS and SOFT LANCETS are indicated to obtain a capillary blood sample from the side of a fingertip for testing utilizing small amounts of blood.

Source page: https://510kreport.com/device/K230712
Methodology: https://510kreport.com/methodology