# K220370: Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)

- Pathway: 510(k) (Traditional)
- Applicant: Tianjin Huahong Technology Co., Ltd.
- Decided: May 19, 2022 after 99 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.
14 later devices descend from it; 7 cite it directly.
0 of 20 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
- K240806: Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.) (2024), 3 descendants of its own
- K221131: Tasso+ (2022), 3 descendants of its own
- K223201: TAP Lancet (2023), 2 descendants of its own
- K260191: Safety lancet (XXXVII) (2026), 1 descendant of its own
- K223208: Safety Lancet (2023), 1 descendant of its own

## Indications for use
The safety lancet is intended for capillary blood sampling.

Source page: https://510kreport.com/device/K220370
Methodology: https://510kreport.com/methodology