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FDA 510(k)

Multi-Lancet Device 2, ReliOn Premier Lancing Device

K-Number: K221175 · 2022-10-17

ApplicantArkray, Inc.
Decision Date2022-10-17
Product CodeQRL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Multi-Lancet Device 2, ReliOn Premier Lancing Device is a medical device manufactured by Arkray, Inc.. It received FDA 510(k) clearance on 2022-10-17 under approval number K221175. 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 Multi-Lancet Device 2, ReliOn Premier Lancing Device?

Multi-Lancet Device 2, ReliOn Premier Lancing Device is a medical device that received FDA 510(k) clearance on 2022-10-17. It is manufactured by Arkray, Inc.. The 510(k) number is K221175.

When was Multi-Lancet Device 2, ReliOn Premier Lancing Device approved by the FDA?

Multi-Lancet Device 2, ReliOn Premier Lancing Device received FDA 510(k) clearance on 2022-10-17, under approval number K221175.

What company makes Multi-Lancet Device 2, ReliOn Premier Lancing Device?

Multi-Lancet Device 2, ReliOn Premier Lancing Device is manufactured by Arkray, Inc..

What is the FDA product code for Multi-Lancet Device 2, ReliOn Premier Lancing Device?

The FDA product code for Multi-Lancet Device 2, ReliOn Premier Lancing Device is QRL.

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Related PubMed Literature

PMID: 42212181 Cybersecurity and Privacy Risks of Generative AI Mental-Health Chatbots: A Systematic Review and Regulatory Framework. Journal of multidisciplinary healthcare (2026) PMID: 42127028 Proposed standards for prosthetic foot reuse and considerations for donation of used prosthetic feet to low-and middle-income countries. PLOS global public health (2026) PMID: 41153261 From Lab to Clinic: Artificial Intelligence with Spectroscopic Liquid Biopsies. Diagnostics (Basel, Switzerland) (2025)

Other Devices by Arkray, Inc.

K160062AUTION ELEVEN Semi-Automated Urinalysis System K200788Assure Titanium Blood Glucose Monitoring System K193514AUTION MAX AX-4060 Urinalysis System K232416AUTION EYE AI-4510 Urine Particle Analysis System

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.

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