# QRL: Multiple Use Blood Lancet For Single Patient Use Only

- Device class: 2; regulation: 21 CFR 878.4850; FDA's rule: 510(k) required
- FDA decisions: 27
- 510(k) review time 2021–2025: median 90 days (middle half 58–142)
- Recalls: 1 (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: 17
- 2023: 3
- 2024: 2
- 2025: 2
- 2026: 3

## Most-cited predicates
- K214022: Accu-Chek Softclix Blood Lancing System (2022), cited by 12
- K220475: Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) (2022), cited by 4
- K243306: Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T) (2024), cited by 3
- K221970: Lancing device (2022), cited by 2
- K221062: RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device (2022), cited by 1

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