510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063151Substantially Equivalent

Humapen Luxura Hd

Eli Lilly and Company, Pharmaceutical Delivery Systems, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063151 is the FDA 510(k) clearance record for HUMAPEN LUXURA HD, a class II device, cleared for Eli Lilly and Co. on under FDA product code NSC (Injector, Pen). FDA's definition for product code NSC reads: "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...". FDA records list 9 510(k) clearances for Eli Lilly and Company, Pharmaceutical Delivery Systems, from to . As of , FDA records show no recalls naming K063151.

Clearance record

Decision date
Received
(85 days to decision)
Product code
NSC Injector, Pen
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Eli Lilly and Co. Lilly Corporate Center, Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NSC

Trailing 12 months

FDA records hold no clearances under product code NSC in the trailing twelve months.

FDA records show no clearances under product code NSC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NSC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260