Cleared Traditional

TRUEdraw Lancing Device, Mini Lancing Device (K221072) - FDA 510(k) Clearance

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

K221072 · Trividia Health · General & Plastic Surgery device
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Oct 2022
Decision
189d
Days
Class 2
Risk

K221072 is an FDA 510(k) clearance for the TRUEdraw Lancing Device, Mini Lancing Device. Classified as Multiple Use Blood Lancet For Single Patient Use Only (product code QRL), Class II - Special Controls.

Submitted by Trividia Health (Fort Lauderdale, US). The FDA issued a Cleared decision on October 18, 2022 after a review of 189 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 Trividia Health devices

Submission Details

510(k) Number K221072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2022
Decision Date October 18, 2022
Days to Decision 189 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
74d slower than avg
Panel avg: 115d · This submission: 189d
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 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 K221072.
LDE4 Lancing Device
K222656 · I-Sens, Inc. · Nov 2022
Disposable Sterile Lancet
K222246 · Tianjin Rilifine Medical Device Co., Ltd. · Nov 2022
Facet Blood Lancets
K222539 · Facet Technologies, LLC · Nov 2022
Multi-Lancet Device 2, ReliOn Premier Lancing Device
K221175 · Arkray, Inc. · 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