Data / Medical devices / United States / Eli Lilly and Company, Pharmaceutical Delivery Systems
Eli Lilly and Company, Pharmaceutical Delivery Systems: FDA-registered device maker in Indianapolis, IN, United States, 3 510(k) clearances
Eli Lilly and Company, Pharmaceutical Delivery Systems is registered with the FDA (registration 1819470) in Indianapolis, IN, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 16, 2022. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1819470
- Address
- Lilly Corporate Center, Indianapolis, IN, United States, 46285
- Owner or operator
- ELI LILLY AND CO. (1819470)
- Roles
- Manufacturer, Specification developer
- First device listed
- January 13, 2016
- Registered through
- 2026
- Brand names listed
- HumaPen Ergo II, HumaPen Savvio, HumatroPen 12mg, HumatroPen 24mg, HumatroPen 6mg, Tempo Smart Button
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Injection Data Capture Device | QOG | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Insulin Autoantibody Kit | OCN | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 16, 2022 | K212217 | Tempo Smart Button | QOG | Substantially Equivalent | Eli Lilly and Company | accessdata.fda.gov |
| June 3, 2016 | K160668 | HumaPen Savvio | FMF | Substantially Equivalent | Eli Lilly and Company, Inc. | accessdata.fda.gov |
| December 30, 2015 | K151686 | HumanPen Ergo II | FMF | Substantially Equivalent | Eli Lilly and Company, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 17, 2011 | 58219 | Not yet classified | Terminated | Forteo [teriparatide (rDNA origin) injection] black starter kits containing Triad alcohol pads. The starter kits look like insulated lunch boxes and contain alcohols pads, needles, instruction guides, and freezer gel pac | Eli Lilly and Company announced 3/17/2011 that patients should not use the alcohol prep pads made by the Triad Group that are contained in the black starter kits for Forteo [teriparatide (rDNA origin) injection] in the United States.The Tri-ad Group is recalling the alcohol prep pads due to potential contamination with the bacteria, Ba-cillus cereus, which c | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Piston
- All makers of Injection Data Capture Device
- All makers of Insulin Autoantibody Kit
Updated September 16, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.