Cleared Traditional

K222656 - LDE4 Lancing Device

K222656 is the FDA 510(k) clearance for LDE4 Lancing Device by I-Sens, Inc.. It is a Class 2 General & Plastic Surgery device (product code QRL) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

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
33d faster than avg
Panel avg: 115d · 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.
TD-5010 Lancing Device and TD-5084 Sterile Lancets
K221419 · Gostar Co., Ltd. · Jan 2023
Lancing System, Sterile Lancet for Single Use, Lancing Device
K222472 · Shandong Lianfa Medical Plastic Products Co. , Ltd. · Nov 2022
Facet Manatee Reusable Lancing Base
K223099 · Facet Technologies, LLC · Nov 2022
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