510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982842Substantially Equivalent

Humapen and Humapen Ergo

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

K982842 is the FDA 510(k) clearance record for HUMAPEN AND HUMAPEN ERGO, a class II device, cleared for Eli Lilly and Co. on under FDA product code FMF (Syringe, Piston). 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 K982842.

Clearance record

Decision date
Received
(44 days to decision)
Product code
FMF Syringe, Piston
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
Third party review
No

Clearances, product code FMF

Trailing 12 months
14 clearances under product code FMF in the twelve months to October 2026, December 2025 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code FMF, trailing twelve months
MonthClearances
November 20251
December 20254
January 20260
February 20261
March 20260
April 20261
May 20261
June 20262
July 20261
August 20263
September 20260
October 20260