# K260191: Safety lancet (XXXVII)

- Pathway: 510(k) (Traditional)
- Applicant: Tianjin Huahong Technology Co., Ltd.
- Decided: Mar 31, 2026 after 68 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.
1 later device descends from it; 1 cites it directly.
0 of 9 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.

## Most influential descendants
- K262526: Safety lancet (XL) (2026), 0 descendants of its own

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

Source page: https://510kreport.com/device/K260191
Methodology: https://510kreport.com/methodology