# K193009: Promisemed Heel Blood Lancet

- Pathway: 510(k) (Traditional)
- Applicant: Promisemed Hangzhou Meditech Co., Ltd.
- Decided: Dec 3, 2019 after 36 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: 2 generations back to K101417 (2010). 2 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130132: Babylance Heel Incision Device, Medipurpose Pte., Ltd. (2013) Summary page 4.

## Most influential descendants
- K210745: Heel Incision Safety Lancet (2021), 5 descendants of its own
- 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

## Indications for use
It is intended for collection of capillary blood from the heel of newborn and premature babies. The lancet has equipped with safety protection features.

Source page: https://510kreport.com/device/K193009
Methodology: https://510kreport.com/methodology