Cleared Traditional

K100988 - HUMAPEN LUXURA HD

K100988 is an FDA 510(k) clearance for HUMAPEN LUXURA HD, 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 130-day FDA review.

K100988 · Eli Lilly and Company · General Hospital
Download Printable Device Report (PDF)
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Aug 2010
Decision
130d
Days
Class 2
Risk

K100988 is an FDA 510(k) clearance for the HUMAPEN LUXURA HD. 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 August 17, 2010 after a review of 130 days - within the typical 510(k) review window.

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 - K100988

510(k) Number K100988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2010
Decision Date August 17, 2010
Days to Decision 130 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
1d slower than avg
Panel avg: 129d · This submission: 130d
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 K100988.
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