# K221371: Promisemed Heel Blood Lancet

- Pathway: 510(k) (Special)
- Applicant: Promisemed Hangzhou Meditech Co., Ltd.
- Decided: Jun 8, 2022 after 27 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.
No later device cites it as a predicate yet.
0 of 4 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 5.

## 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/K221371
Methodology: https://510kreport.com/methodology