Cleared Traditional

Facet Blood Lancets (K222539) - FDA 510(k) Clearance

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

K222539 · Facet Technologies, LLC · General & Plastic Surgery device
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Nov 2022
Decision
88d
Days
Class 2
Risk

K222539 is an FDA 510(k) clearance for the Facet Blood Lancets. Classified as Multiple Use Blood Lancet For Single Patient Use Only (product code QRL), Class II - Special Controls.

Submitted by Facet Technologies, LLC (Atlanta, US). The FDA issued a Cleared decision on November 18, 2022 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Facet Technologies, LLC devices

Submission Details

510(k) Number K222539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2022
Decision Date November 18, 2022
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
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 K222539.
Facet Manatee Reusable Lancing Base
K223099 · Facet Technologies, LLC · Nov 2022
LDE4 Lancing Device
K222656 · I-Sens, Inc. · Nov 2022
Disposable Sterile Lancet
K222246 · Tianjin Rilifine Medical Device Co., Ltd. · Nov 2022
TRUEdraw Lancing Device, Mini Lancing Device
K221072 · Trividia Health · Oct 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