Cleared Traditional

K222246 - Disposable Sterile Lancet (FDA 510(k) Clearance)

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

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

Submission Details

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
4d slower than avg
Panel avg: 114d · This submission: 118d
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 K222246.
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