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

FDA 510(k)

Medipoint Blood Lancets

K-Number: K223480 · 2023-01-13

ApplicantMedipoint Holdings, LLC
Decision Date2023-01-13
Product CodeQRK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medipoint Blood Lancets is the device name listed in this FDA 510(k) record. The listed applicant is Medipoint Holdings, LLC. It received FDA 510(k) clearance on 2023-01-13 under 510(k) number K223480. The device is classified under product code QRK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medipoint Blood Lancets?

Medipoint Blood Lancets is a medical device that received FDA 510(k) clearance on 2023-01-13. The listed applicant is Medipoint Holdings, LLC. The 510(k) number is K223480.

When did Medipoint Blood Lancets receive FDA 510(k) clearance?

Medipoint Blood Lancets received FDA 510(k) clearance on 2023-01-13, under 510(k) number K223480.

Who is the listed applicant for Medipoint Blood Lancets?

The FDA 510(k) record lists Medipoint Holdings, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medipoint Blood Lancets?

The FDA product code for Medipoint Blood Lancets is QRK.

Related Devices (Code: QRK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261634Disposable Blood Lancet (Soft)SteriLance Medical (Suzhou), Inc.K250016droplet® personal lancetsHtl-Strefa S.AK244031Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)SteriLance Medical (Suzhou), Inc.K242622Sterile Lancets for Single UseNingbo Caremed Medical Products Co., Ltd.K241810MICROLET®NEXT LancetAscensia Diabetes Care U.S., Inc.K232330Lancing SystemNingbo Medsun Medical Co., Ltd.

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.

↑