# K242316: Safety Lancet

- Pathway: 510(k) (Special)
- Applicant: Ningbo Medsun Medical Co., Ltd.
- Decided: Aug 28, 2024 after 23 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: 4 generations back to K822209 (1982). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222090: Safety Lancet, Ningbo Medsun Medical Co., Ltd. (2022) Summary page 4.

## Indications for use
Safety Lancet is intended to be used to obtain capillary blood sample to perform medical testing, including blood glucose monitoring and for tests using small amounts of blood.

Source page: https://510kreport.com/device/K242316
Methodology: https://510kreport.com/methodology