Cleared Traditional

K222656 - LDE4 Lancing Device (FDA 510(k) Clearance)

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

K222656 · I-Sens, Inc. · General & Plastic Surgery device
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Nov 2022
Decision
82d
Days
Class 2
Risk

K222656 is an FDA 510(k) clearance for the LDE4 Lancing Device. Classified as Multiple Use Blood Lancet For Single Patient Use Only (product code QRL), Class II - Special Controls.

Submitted by I-Sens, Inc. (Seoul, KR). The FDA issued a Cleared decision on November 23, 2022 after a review of 82 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 I-Sens, Inc. devices

Submission Details

510(k) Number K222656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2022
Decision Date November 23, 2022
Days to Decision 82 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
32d faster than avg
Panel avg: 114d · This submission: 82d
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 K222656.
Lancing device (HH-XV-T)
K253706 · Tianjin Huahong Technology Co., Ltd. · Dec 2025
MICROLET®NEXT 2 Lancing Device
K250813 · Ascensia Diabetes Care U.S., Inc. · May 2025
Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX)
K243306 · Tianjin Huahong Technology Co., Ltd. · Nov 2024
Facet Aurora Reusable Lancet Base
K232912 · Facet Technologies, LLC · Jan 2024
Verifine® Ease Lancing Device, Verifine® Lancing Device
K223643 · Promisemed Hangzhou Meditech Co., Ltd. · Feb 2023
RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device
K221062 · Bionime Corporation · Sep 2022