Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Disposable Blood Lancets

K-Number: K220387 · 2022-08-17

ApplicantSuzhou Kyuan Medical Apparatus Co., Ltd.
Decision Date2022-08-17
Product CodeQRL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Blood Lancets is a medical device manufactured by Suzhou Kyuan Medical Apparatus Co., Ltd.. It received FDA 510(k) clearance on 2022-08-17 under approval number K220387. The device is classified under product code QRL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Blood Lancets?

Disposable Blood Lancets is a medical device that received FDA 510(k) clearance on 2022-08-17. It is manufactured by Suzhou Kyuan Medical Apparatus Co., Ltd.. The 510(k) number is K220387.

When was Disposable Blood Lancets approved by the FDA?

Disposable Blood Lancets received FDA 510(k) clearance on 2022-08-17, under approval number K220387.

What company makes Disposable Blood Lancets?

Disposable Blood Lancets is manufactured by Suzhou Kyuan Medical Apparatus Co., Ltd..

What is the FDA product code for Disposable Blood Lancets?

The FDA product code for Disposable Blood Lancets is QRL.

Related Clinical Trials

NCT07273877 "Real-world Assessment of BP Control in Patients With Hypertension by the Netrod RDN System" - REACH-RDN ENROLLING_BY_INVITATION

Other Devices by Suzhou Kyuan Medical Apparatus Co., Ltd.

K221778Disposable Safety Lancets

Related Devices (Code: QRL)

K222472Lancing System, Sterile Lancet for Single Use, Lancing DeviceShandong Lianfa Medical Plastic Products Co. , Ltd. K223099Facet Manatee Reusable Lancing BaseFacet Technologies, LLC K222656LDE4 Lancing DeviceI-Sens, Inc. K222246Disposable Sterile LancetTianjin Rilifine Medical Device Co., Ltd. K222539Facet Blood LancetsFacet Technologies, LLC K221072TRUEdraw Lancing Device, Mini Lancing DeviceTrividia Health

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑