Cleared Traditional

Multi-Lancet Device 2, ReliOn Premier Lancing Device (K221175) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221175 · Arkray, Inc. · General & Plastic Surgery device
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Oct 2022
Decision
175d
Days
Class 2
Risk

K221175 is an FDA 510(k) clearance for the Multi-Lancet Device 2, ReliOn Premier Lancing Device. Classified as Multiple Use Blood Lancet For Single Patient Use Only (product code QRL), Class II - Special Controls.

Submitted by Arkray, Inc. (Kyoto, JP). The FDA issued a Cleared decision on October 17, 2022 after a review of 175 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4850 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Arkray, Inc. devices

Submission Details

510(k) Number K221175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2022
Decision Date October 17, 2022
Days to Decision 175 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 115d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QRL Multiple Use Blood Lancet For Single Patient Use Only
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4850
Definition A Multiple Use Capable Blood Lancet Intended For Use On A Single Patient That Is Comprised Of A Single Use Blade Attached To A Solid, Reusable Base That Is Used To Puncture The Skin To Obtain A Drop Of Blood For Diagnostic Purposes.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Arkray Factory USA, Inc.
Joe Dempsey

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QRL Multiple Use Blood Lancet For Single Patient Use Only

All 23
Devices cleared under the same product code (QRL) and FDA review panel - the closest regulatory comparables to K221175.
Disposable Sterile Lancet
K222246 · Tianjin Rilifine Medical Device Co., Ltd. · Nov 2022
Facet Blood Lancets
K222539 · Facet Technologies, LLC · Nov 2022
TRUEdraw Lancing Device, Mini Lancing Device
K221072 · Trividia Health · Oct 2022
Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets
K221613 · Owen Mumford, Ltd. · Oct 2022
RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device
K221062 · Bionime Corporation · Sep 2022
RightLance Blood Lancing System
K222034 · Beijing Ruicheng Medical Supplies Co., Ltd. · Sep 2022