# K221507: Disposable Blood Lancet

- Pathway: 510(k) (Traditional)
- Applicant: SteriLance Medical (Suzhou), Inc.
- Decided: Aug 31, 2022 after 100 days
- Product code: QRK (Single Use Only Blood Lancet Without 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.
5 later devices descend from it; 4 cite it directly.
0 of 11 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
- K244031: Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense) (2025), 1 descendant of its own
- K262631: Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense) (2026), 0 descendants of its own
- K261634: Disposable Blood Lancet (Soft) (2026), 0 descendants of its own
- K250016: droplet® personal lancets (2025), 0 descendants of its own
- K241810: MICROLET®NEXT Lancet (2024), 0 descendants of its own

## Indications for use
Disposable Blood Lancet is used for capillary blood collection.

Source page: https://510kreport.com/device/K221507
Methodology: https://510kreport.com/methodology