Cleared Traditional

K142518 - HumaPen Luxura

K142518 is an FDA 510(k) clearance for HumaPen Luxura, manufactured by Eli Lilly and Company. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K142518 · Eli Lilly and Company · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
270d
Days
Class 2
Risk

K142518 is an FDA 510(k) clearance for the HumaPen Luxura. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Eli Lilly and Company (Indianapolis, US). The FDA issued a Cleared decision on June 5, 2015 after a review of 270 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Eli Lilly and Company devices

FDA 510(k) Submission Details - K142518

510(k) Number K142518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2014
Decision Date June 05, 2015
Days to Decision 270 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 129d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 330
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K142518.
LITe BIO Delivery System
K160978 · Stryker Corporation · Jul 2016
Merit 20 mL Syringe
K152783 · Merit Medical Systems, Inc. · Dec 2015
BD Single Use, Hypodermic Syringe
K151766 · Becton, Dickinson and Company · Sep 2015
ConMed Mixing and Delivery Kit
K142535 · Conmed Corporation · Apr 2015
Merit 10mL Syringe
K142636 · Merit Medical Systems, Inc. · Oct 2014
PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM
K141762 · Biomet, Inc. · Aug 2014