510(k) K253706

Lancing device (HH-XV-T) by Tianjin Huahong Technology Co., Ltd. — Product Code QRL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 9, 2025
Date Received: November 24, 2025
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Multiple Use Blood Lancet For Single Patient Use Only
Device Class: Class II
Regulation Number: 878.4850
Review Panel: SU
Submission Type

A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.

Other clearances by Tianjin Huahong Technology Co., Ltd.

K252490 — Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) (February 12, 2026)
K251694 — safety lancet (June 26, 2025)
K243306 — Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); La (November 15, 2024)
K241627 — Safety Lancet (XXXV) (June 20, 2024)
K240806 — Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.) (May 21, 2024)
K220475 — Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T (July 6, 2022)
K221176 — Insulin Pen Needle (July 1, 2022)
K220370 — Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI) (May 19, 2022)
K220372 — Heel Stick Safety Lancet (HHZ-II, HHZ-III) (May 17, 2022)
K202319 — Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) (November 12, 2021)

Other clearances for product code QRL

K250813 — MICROLET®NEXT 2 Lancing Device (May 14, 2025)
K243306 — Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); La (November 15, 2024)
K232912 — Facet Aurora Reusable Lancet Base (January 25, 2024)
K231797 — Medifun Lancing Device, Model No. LD-E1 (November 22, 2023)
K223643 — Verifine® Ease Lancing Device, Verifine® Lancing Device (February 21, 2023)
K221419 — TD-5010 Lancing Device and TD-5084 Sterile Lancets (January 20, 2023)
K222472 — Lancing System, Sterile Lancet for Single Use, Lancing Device (November 30, 2022)
K223099 — Facet Manatee Reusable Lancing Base (November 28, 2022)
K222656 — LDE4 Lancing Device (November 23, 2022)
K222246 — Disposable Sterile Lancet (November 21, 2022)