Cleared Traditional

K231797 - Medifun Lancing Device, Model No. LD-E1 (FDA 510(k) Clearance)

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

K231797 · Medifun Corporation · General & Plastic Surgery device
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Nov 2023
Decision
155d
Days
Class 2
Risk

K231797 is an FDA 510(k) clearance for the Medifun Lancing Device, Model No. LD-E1. Classified as Multiple Use Blood Lancet For Single Patient Use Only (product code QRL), Class II - Special Controls.

Submitted by Medifun Corporation (Taichung City, TW). The FDA issued a Cleared decision on November 22, 2023 after a review of 155 days - an extended review 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: 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 Medifun Corporation devices

Submission Details

510(k) Number K231797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2023
Decision Date November 22, 2023
Days to Decision 155 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
41d slower than avg
Panel avg: 114d · This submission: 155d
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 Consultant

Voler Biotech Consulting CO., Ltd.
Tyra Chiu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K231797.
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
TD-5010 Lancing Device and TD-5084 Sterile Lancets
K221419 · Gostar Co., Ltd. · Jan 2023