# K221839: Lancet

- Pathway: 510(k) (Traditional)
- Applicant: Hebei Xinle Sci&Tech Co., Ltd.
- Decided: Sep 19, 2022 after 87 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 K822209 (1982). 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)
- K192666: Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet, Promisemed Hangzhou Meditech Co., Ltd. (2019) Summary page 5.

## Indications for use
It is intended for capillary blood sampling.

Source page: https://510kreport.com/device/K221839
Methodology: https://510kreport.com/methodology