510(k) Report

FDA applicant

Eli Lilly and Company

Indianapolis, IN9 decisions1998–20220 recalls

FDA records 9 decisions for Eli Lilly and Company (Indianapolis, IN) from 1998 to 2022: 9 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and QOG (Injection Data Capture Device). Its devices cite 8 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Eli Lilly and Co.”, “Eli Lilly and Company, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Eli Lilly and Company’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2007: 12010: 12015: 22016: 22022: 1
2007high 2 (2015) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Eli Lilly and Company by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Eli Lilly and Company’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FMFSyringe, Piston6decisions
  • QOGInjection Data Capture Device1decision
  • NSCInjector, Pen1decision
  • NDCCalculator, Drug Dose1decision

Whose devices does it build on?

Its devices cite 8 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K982842Humapen and Humapen ErgoEli Lilly and Co. · 19983cite it
  • K142518HumaPen LuxuraEli Lilly and Company · 20152cite it
  • K212217Tempo Smart ButtonEli Lilly and Company · 20221cites it
  • K063151Humapen Luxura HDEli Lilly and Co. · 20071cites it
  • K053563Humapen MemoirEli Lilly and Company · 20061cites it
  • K100988Humapen Luxura HDEli Lilly and Company · 20101cites it

What has FDA decided for it lately?

  • K212217Tempo Smart ButtonEli Lilly and Company · 2022
  • K160949Go Dose SystemEli Lilly and Company · 2016
  • K160668HumaPen SavvioEli Lilly and Company, Inc. · 2016
  • K151686HumanPen Ergo IIEli Lilly and Company, Inc. · 2015
  • K142518HumaPen LuxuraEli Lilly and Company · 2015
  • K100988Humapen Luxura HDEli Lilly and Company · 2010
  • K063151Humapen Luxura HDEli Lilly and Co. · 2007
  • K053563Humapen MemoirEli Lilly and Company · 2006

All 5 as Eli Lilly and Company →All 2 as Eli Lilly and Co. →All 2 as Eli Lilly and Company, Inc. →