# K233796: Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro)

- Pathway: 510(k) (Traditional)
- Applicant: SteriLance Medical (Suzhou), Inc.
- Decided: Jan 16, 2024 after 48 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)
- K221521: Disposable Safety Lancet, SteriLance Medical (Suzhou), Inc. (2022) Summary page 4.

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

Source page: https://510kreport.com/device/K233796
Methodology: https://510kreport.com/methodology