# K232330: Lancing System

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Medsun Medical Co., Ltd.
- Decided: Jan 4, 2024 after 154 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: 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
Lancet: Lancet is intended to be used to obtain capillary blood sample for self-monitoring of blood glucose. Lancing Device: Lancing Device is used with lancets to draw a capillary blood sample for testing, utilizing small amounts of blood. The Lancing Device is intended for use by a single patient and should not be shared.

Source page: https://510kreport.com/device/K232330
Methodology: https://510kreport.com/methodology