Cleared Traditional

HUMAPEN LUXURA HD (K063151) - FDA 510(k) Clearance

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

K063151 · Eli Lilly and Co. · General Hospital
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Optimized for regulatory review, auditing and printing
Jan 2007
Decision
85d
Days
Class 2
Risk

K063151 is an FDA 510(k) clearance for the HUMAPEN LUXURA HD. Classified as Injector, Pen (product code NSC), Class II - Special Controls.

Submitted by Eli Lilly and Co. (Indianapolis, US). The FDA issued a Cleared decision on January 9, 2007 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Eli Lilly and Co. devices

Submission Details

510(k) Number K063151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2006
Decision Date January 09, 2007
Days to Decision 85 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
44d faster than avg
Panel avg: 129d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NSC Injector, Pen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
Definition A Pen Injector Is A Device That Provides A Nonelectrically-powered, Mechanically-operated Method Of Accurately Injecting A Dose Of Medicinal Product From A Medicinal Cartridge, Reservoir, Or Syringe Through A Manually-inserted Single Lumen Hypodermic Needle. The Device Can Be Used By Health Professionals Or For Self-injection By The Patient.
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.