Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)— 510(k) K260122

Name: FDA 510(k) clearance K260122
Creator: U.S. Food and Drug Administration
Published: 2026-07-06

Substantially Equivalent

SteriLance Medical (Suzhou), Inc.

FDA 510(k) clearance K260122 for Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep), Substantially Equivalent on 2026-07-06. Applicant: SteriLance Medical (Suzhou), Inc.. Device class: 2.

Clearance details

Applicant: SteriLance Medical (Suzhou), Inc.
Product code: Code QRL
Device class: Class 2
Regulation: 21 CFR 878.4850
Advisory panel: General, Plastic Surgery
Date received: 2026-01-15
Decision date: 2026-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code QRL

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K262135 — Lancing device2026-08-18
K262211 — Lancet2026-07-22
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 SteriLance Medical (Suzhou), Inc.

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K262631 — Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)2026-08-25
K261634 — Disposable Blood Lancet (Soft)2026-06-12
K244031 — Disposable Blood Lancet (4 models)2025-02-26
K244036 — Heel Incision Safety Lancet (SteriHeel 2)2025-02-26
K233796 — Disposable safety lancet (Impress) +4 more2024-01-16

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.