Eli Lilly and Company: FDA clearances and approvals
Eli Lilly and Company has 7 FDA 510(k) clearances (first 2006, latest 2022), across 3 product codes in 2 review panels. Median 510(k) review time: 190 days. openFDA lists 1 product recall by a recalling firm named Eli Lilly and Company. It is the industry lead sponsor of 29 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 2 | 230 |
| 2016 | 2 | 174 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 427 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Eli Lilly and Company's cleared 510(k)s took a median 427 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 159 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMF | Syringe, Piston | 5 | 5 |
| NDC | Calculator, Drug Dose | 1 | 1 |
| QOG | Injection Data Capture Device | 1 | 1 |
Review panels
Most recent Eli Lilly and Company 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212217 | Tempo Smart Button | QOG | 2022-09-16 | 427 |
| K160949 | Go Dose System | NDC | 2016-12-22 | 261 |
| K160668 | HumaPen Savvio | FMF | 2016-06-03 | 86 |
| K151686 | HumanPen Ergo II | FMF | 2015-12-30 | 190 |
| K142518 | HumaPen Luxura | FMF | 2015-06-05 | 270 |
| K100988 | HUMAPEN LUXURA HD | FMF | 2010-08-17 | 130 |
| K053563 | HUMAPEN MEMOIR | FMF | 2006-04-07 | 107 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2011-03-17.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Eli Lilly and Company is the industry lead sponsor of 29 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06516913: A Study of Subcutaneous Injection in Healthy Participants (Completed, started 2024-07-22)
- NCT05893797: A Study of LY8888AX in Participants Using a Connected Insulin Management Platform (Completed, started 2023-10-05)
- NCT06003465: A Research Study Looking at Similarity Between LY3437943 Versions for Different Injection Devices (Completed, started 2023-08-29)
- NCT05810597: A Research Study Looking at Similarity Between Tirzepatide Versions for Different Injection Devices (Completed, started 2023-04-03)
- NCT05692869: A Study of Continuous Blood Pressure Monitoring in Healthy Participants (Completed, started 2023-01-31)
Frequently asked questions
How many FDA 510(k) clearances does Eli Lilly and Company have?
Eli Lilly and Company has 7 FDA 510(k) clearances (first 2006, latest 2022), across 3 product codes in 2 review panels.
How long does FDA take to clear Eli Lilly and Company's 510(k)s?
The median time from FDA receipt to decision across Eli Lilly and Company's cleared 510(k)s is 190 days.
What devices does Eli Lilly and Company make?
Its most frequent FDA product codes are FMF (Syringe, Piston, 5); NDC (Calculator, Drug Dose, 1); QOG (Injection Data Capture Device, 1).
Has Eli Lilly and Company had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Eli Lilly and Company; the most recent began 2011-03-17. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 7 Eli Lilly and Company clearances with predicates and recalls
- Run predicate analysis for product code FMF, Eli Lilly and Company's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.