# K222246: Disposable Sterile Lancet

- Pathway: 510(k) (Traditional)
- Applicant: Tianjin Rilifine Medical Device Co., Ltd.
- Decided: Nov 21, 2022 after 118 days
- Product code: QRL (Multiple Use Blood Lancet For Single Patient Use Only)
- 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: 4 generations back to K002134 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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), Tianjin Huahong Technology Co., Ltd. (2022) Summary page 4.

## Indications for use
Disposable Sterile Lancet: The lancet is intended for capillary blood sampling. Lancing Device: The Lancing Device is used with lancets to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. The Lancing Device is single patient use only and should not be shared with anyone else, even a family member.

Source page: https://510kreport.com/device/K222246
Methodology: https://510kreport.com/methodology