# K251694: safety lancet

- Pathway: 510(k) (Special)
- Applicant: Tianjin Huahong Technology Co., Ltd.
- Decided: Jun 26, 2025 after 24 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: 5 generations back to K822209 (1982). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240806: Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.), Tianjin Huahong Technology Co., Ltd. (2024) Summary page 5.

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

Source page: https://510kreport.com/device/K251694
Methodology: https://510kreport.com/methodology