# 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)

- Pathway: 510(k) (Special)
- Applicant: Tianjin Huahong Technology Co., Ltd.
- Decided: Nov 15, 2024 after 25 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.
3 later devices descend from it; 3 cite it directly.
0 of 13 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 5.

## Most influential descendants
- K262135: Lancing device (2026), 0 descendants of its own
- K262211: Lancet (2026), 0 descendants of its own
- K253706: Lancing device (HH-XV-T) (2025), 0 descendants of its own

## Indications for use
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 intended to be used by a single patient and should not be shared. (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) The Lancing Device is used with lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared. (HH-XXVII-T)

Source page: https://510kreport.com/device/K243306
Methodology: https://510kreport.com/methodology