# K221368: Promisemed Blood Lancet,  VeriFine Safety Lancet, VeriFine Mini-Safety Lancet

- Pathway: 510(k) (Special)
- Applicant: Promisemed Hangzhou Meditech Co., Ltd.
- Decided: Jun 9, 2022 after 28 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.
4 later devices descend from it; 4 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)
- K192666: Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet, Promisemed Hangzhou Meditech Co., Ltd. (2019) Summary page 4.

## Most influential descendants
- K261045: Verifine Safety Lancets (2026), 0 descendants of its own
- K243533: Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus (2025), 0 descendants of its own
- K222408: Disposable Safety Lancet (2022), 0 descendants of its own
- K221783: SafetiCET Safety Lancet (2022), 0 descendants of its own

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

Source page: https://510kreport.com/device/K221368
Methodology: https://510kreport.com/methodology