# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Tianjin Huahong Technology Co., Ltd.
- Decided: Jul 6, 2022 after 138 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: 3 generations back to K002134 (2000). 8 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192666: Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet, Promisemed Hangzhou Meditech Co., Ltd. (2019) Summary page 4.
- K113332: ON Call Chosen Lancing Device, ACON Laboratories, Inc. (2012) Summary page 4.

## Most influential descendants
- 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), 3 descendants of its own
- 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
- K242622: Sterile Lancets for Single Use (2024), 0 descendants of its own

## Indications for use
Lancet is intended for capillary blood sampling. 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.

Source page: https://510kreport.com/device/K220475
Methodology: https://510kreport.com/methodology