# K221778: Disposable Safety Lancets

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Kyuan Medical Apparatus Co., Ltd.
- Decided: Oct 3, 2022 after 104 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.
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)
- K101145: Surgilance Safety Lancets, Models SLN100, SLN200, SLN240, SLN300, SLB200, SLB250, Medipurpose Pte., Ltd. (2010) Summary page 4.

## Indications for use
The Disposable Safety Lancets is intended to be used in a hospital or at home to obtain capillary blood samples from the fingertip for tests using small amounts of blood. The device contains a sharp injury protection feature.

Source page: https://510kreport.com/device/K221778
Methodology: https://510kreport.com/methodology