# K252490: Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)

- Pathway: 510(k) (Special)
- Applicant: Tianjin Huahong Technology Co., Ltd.
- Decided: Feb 12, 2026 after 188 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 K101417 (2010). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220372: Heel Stick Safety Lancet (HHZ-II, HHZ-III), Tianjin Huahong Technology Co., Ltd. (2022) Summary page 5.

## Indications for use
Heel Stick Safety Lancet is intended for the collection of capillary blood from the heel of newborn, preemie, and toddler. The lancet has equipped with safety protection features.

Source page: https://510kreport.com/device/K252490
Methodology: https://510kreport.com/methodology