Cleared Traditional

K222246 - Disposable Sterile Lancet

K222246 is an FDA 510(k) clearance for Disposable Sterile Lancet, manufactured by Tianjin Rilifine Medical Device Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code QRL cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K222246 · Tianjin Rilifine Medical Device Co., Ltd. · General & Plastic Surgery device
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Nov 2022
Decision
118d
Days
Class 2
Risk

K222246 is an FDA 510(k) clearance for the Disposable Sterile Lancet. Classified as Multiple Use Blood Lancet For Single Patient Use Only (product code QRL), Class II - Special Controls.

Submitted by Tianjin Rilifine Medical Device Co., Ltd. (Tianjin, CN). The FDA issued a Cleared decision on November 21, 2022 after a review of 118 days - within the typical 510(k) review window.

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 Tianjin Rilifine Medical Device Co., Ltd. devices

FDA 510(k) Submission Details - K222246

510(k) Number K222246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2022
Decision Date November 21, 2022
Days to Decision 118 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
3d slower than avg
Panel avg: 115d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QRL Device Classification - Class 2, Special Controls

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 K222246.
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
LDE4 Lancing Device
K222656 · I-Sens, Inc. · Nov 2022
Facet Blood Lancets
K222539 · Facet Technologies, LLC · 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