# K210745: Heel Incision Safety Lancet

- Pathway: 510(k) (Traditional)
- Applicant: SteriLance Medical (Suzhou), Inc.
- Decided: Aug 26, 2021 after 167 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: 3 generations back to K101417 (2010). 3 ancestors in all.
5 later devices descend from it; 4 cite 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)
- K193009: Promisemed Heel Blood Lancet, Promisemed Hangzhou Meditech Co., Ltd. (2019) Summary page 4.

## Most influential descendants
- K220372: Heel Stick Safety Lancet (HHZ-II, HHZ-III) (2022), 1 descendant of its own
- K253605: Safety Heel Lancet (2026), 0 descendants of its own
- K252490: Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) (2026), 0 descendants of its own
- K244036: Heel Incision Safety Lancet (SteriHeel 2) (2025), 0 descendants of its own
- K222168: Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler (2022), 0 descendants of its own

## Indications for use
Heel Incision 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/K210745
Methodology: https://510kreport.com/methodology