# K221521: Disposable Safety Lancet

- Pathway: 510(k) (Traditional)
- Applicant: SteriLance Medical (Suzhou), Inc.
- Decided: Oct 28, 2022 after 156 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). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192666: Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet, Promisemed Hangzhou Meditech Co., Ltd. (2019) Summary page 4.

## Most influential descendants
- K233796: Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro) (2024), 0 descendants of its own

## Indications for use
The disposable safety lancet is used to obtain capillary blood samples. The device has an integral sharps injury prevention feature

Source page: https://510kreport.com/device/K221521
Methodology: https://510kreport.com/methodology