# K244036: Heel Incision Safety Lancet (SteriHeel 2)

- Pathway: 510(k) (Traditional)
- Applicant: SteriLance Medical (Suzhou), Inc.
- Decided: Feb 26, 2025 after 58 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 K101417 (2010). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210745: Heel Incision Safety Lancet, SteriLance Medical (Suzhou), Inc. (2021) Summary page 5.

## Indications for use
Heel Incision Safety Lancet is intended for capillary blood sampling from the heel of newborns, preemies and toddlers.

Source page: https://510kreport.com/device/K244036
Methodology: https://510kreport.com/methodology