# QRK: Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

- Device class: 2; regulation: 21 CFR 878.4850; FDA's rule: 510(k) required
- FDA decisions: 17
- 510(k) review time 2021–2025: median 89 days (middle half 58–167)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2022: 3
- 2023: 7
- 2024: 3
- 2025: 2
- 2026: 2

## Most-cited predicates
- K221507: Disposable Blood Lancet (2022), cited by 4
- K244031: Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense) (2025), cited by 1
- K221433: Facet 28G Universal Lancet (2022), cited by 1

Source page: https://510kreport.com/product-code/QRK
Data by year (CSV): https://510kreport.com/product-code/QRK.csv