Disposable Safety Lancets— 510(k) K221778

Name: FDA 510(k) clearance K221778
Creator: U.S. Food and Drug Administration
Published: 2022-10-03

Substantially Equivalent

Suzhou Kyuan Medical Apparatus Co., Ltd.

FDA 510(k) clearance K221778 for Disposable Safety Lancets, Substantially Equivalent on 2022-10-03. Applicant: Suzhou Kyuan Medical Apparatus Co., Ltd.. Device class: 2.

Clearance details

Applicant: Suzhou Kyuan Medical Apparatus Co., Ltd.
Product code: Code FMK
Device class: Class 2
Regulation: 21 CFR 878.4850
Advisory panel: General, Plastic Surgery
Date received: 2022-06-21
Decision date: 2022-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

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K262526 — Safety lancet (XL)2026-09-13
K261045 — Verifine Safety Lancets2026-05-01
K260191 — Safety lancet (XXXVII)2026-03-31
K253605 — Safety Heel Lancet2026-02-20
K252490 — Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)2026-02-12

More clearances from Suzhou Kyuan Medical Apparatus Co., Ltd.

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K220387 — Disposable Blood Lancets2022-08-17

Adverse events under product code FMK

product code FMK

Injury: 133
Malfunction: 1,278
Other: 1
Total: 1,412

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.