Cleared Traditional

K024170 - L1 SYSTEM

K024170 is an FDA 510(k) clearance for L1 SYSTEM, manufactured by Pelikan Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FMK cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K024170 · Pelikan Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
117d
Days
Class 2
Risk

K024170 is an FDA 510(k) clearance for the L1 SYSTEM. Classified as Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (product code FMK), Class II - Special Controls.

Submitted by Pelikan Technologies, Inc. (Palo Alto, US). The FDA issued a Cleared decision on April 14, 2003 after a review of 117 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.

FDA 510(k) Submission Details - K024170

510(k) Number K024170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2002
Decision Date April 14, 2003
Days to Decision 117 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
2d slower than avg
Panel avg: 115d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMK Device Classification - Class 2, Special Controls

Product Code FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4850
Definition A Disposable Blood Lancet Intended For A Single Use That Is Comprised Of A Single Use Blade Attached To A Solid, Non-reusable Base (including An Integral Sharps Injury Prevention Feature) That Is Used To Puncture The Skin To Obtain A Drop Of Blood For Diagnostic Purposes. The Integral Sharps Injury Prevention Feature Allows The Device To Be Used Once And Then Renders It Inoperable And Incapable Of Further Use.
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 - FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

All 109
Devices cleared under the same product code (FMK) and FDA review panel - the closest regulatory comparables to K024170.
SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250
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K101417 · Medipurpose Pte. , Ltd. · Oct 2010
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K041665 · Pelikan Technologies, Inc. · Jul 2004
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K001162 · Mali-Tech , Ltd. · Aug 2000
FREE-LANCE
K944948 · F.F.F. Enterprises, Inc. · Nov 1994
JENNINGS JAVELIN
K942548 · Jfi Endineering, Inc. · Nov 1994
K024170 · L1 SYSTEM
Download PDF FDA Summary Pelikan Technologies,…