OneTouch Delica Plus Lancing System— 510(k) K221546

Name: FDA 510(k) clearance K221546
Creator: U.S. Food and Drug Administration
Published: 2022-08-23

Substantially Equivalent

Asahi Polyslider Co., Ltd.

FDA 510(k) clearance K221546 for OneTouch Delica Plus Lancing System, Substantially Equivalent on 2022-08-23. Applicant: Asahi Polyslider Co., Ltd.. Device class: 2.

Clearance details

Applicant: Asahi Polyslider Co., Ltd.
Product code: Code QRL
Device class: Class 2
Regulation: 21 CFR 878.4850
Advisory panel: General, Plastic Surgery
Date received: 2022-05-27
Decision date: 2022-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maniwa, JP

Download summary PDF View on FDA.gov ↗

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K262135 — Lancing device2026-08-18
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

More clearances from Asahi Polyslider Co., Ltd.

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K222084 — OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie2022-11-02

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.