# K223208: Safety Lancet

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Zhenwu Medical Co., Ltd.
- Decided: Feb 10, 2023 after 116 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.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220370: Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI), Tianjin Huahong Technology Co., Ltd. (2022) Summary page 4.

## Most influential descendants
- K223826: NanoDrop Lancet (2024), 0 descendants of its own

## Indications for use
The safety lancet is intended for capillary blood sampling.

Source page: https://510kreport.com/device/K223208
Methodology: https://510kreport.com/methodology