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510(k) 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) by Tianjin Huahong Technology Co., Ltd. — Product Code QRL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2024
Date Received
October 21, 2024
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)
  • K253706 — Lancing device (HH-XV-T) (December 9, 2025)
  • K251694 — safety lancet (June 26, 2025)
  • 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

  • K253706 — Lancing device (HH-XV-T) (December 9, 2025)
  • K250813 — MICROLET®NEXT 2 Lancing Device (May 14, 2025)
  • 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)