Lancing device— 510(k) K262135

Name: FDA 510(k) clearance K262135
Creator: U.S. Food and Drug Administration
Published: 2026-08-18

Substantially Equivalent

Tianjin Huahong Technology Co., Ltd.

FDA 510(k) clearance K262135 for Lancing device, Substantially Equivalent on 2026-08-18. Applicant: Tianjin Huahong Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Tianjin Huahong Technology Co., Ltd.
Product code: Code QRL
Device class: Class 2
Regulation: 21 CFR 878.4850
Advisory panel: General, Plastic Surgery
Date received: 2026-06-25
Decision date: 2026-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tianjin, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code QRL

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K262211 — Lancet2026-07-22
K260122 — Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)2026-07-06
K253706 — Lancing device (HH-XV-T)2025-12-09
K250813 — MICROLET®NEXT 2 Lancing Device2025-05-14
K243306 — Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX) +1 more2024-11-15

More clearances from Tianjin Huahong Technology Co., Ltd.

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K260845 — Huahong Sharps Container (HHR-I, HHR-II)2026-08-05
K260191 — Safety lancet (XXXVII)2026-03-31
K252490 — Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)2026-02-12
K251694 — safety lancet2025-06-26
K241627 — Safety Lancet (XXXV)2024-06-20

Adverse events under product code QRL

product code QRL

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.