MedtFine Blood Lancet— 510(k) K221383

Name: FDA 510(k) clearance K221383
Creator: U.S. Food and Drug Administration
Published: 2022-09-21

Substantially Equivalent

Shanghai Carelife International Trading Co. , Ltd.

FDA 510(k) clearance K221383 for MedtFine Blood Lancet, Substantially Equivalent on 2022-09-21. Applicant: Shanghai Carelife International Trading Co. , Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai Carelife International Trading Co. , Ltd.
Product code: Code QRK
Device class: Class 2
Regulation: 21 CFR 878.4850
Advisory panel: General, Plastic Surgery
Date received: 2022-05-13
Decision date: 2022-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code QRK

view all

K262631 — Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)2026-08-25
K261634 — Disposable Blood Lancet (Soft)2026-06-12
K250016 — droplet® personal lancets2025-07-01
K244031 — Disposable Blood Lancet (4 models)2025-02-26
K242622 — Sterile Lancets for Single Use2024-10-28

More clearances from Shanghai Carelife International Trading Co. , Ltd.

view all

K131954 — MEDI PEN NEEDLE2014-05-29

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