Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Eli Lilly and Company — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
261 daysmedian FDA review time
427 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212217 | Tempo Smart Button | Eli Lilly and Company | 2022-09-16 | 427 | 0 |
| K160949 | Go Dose System | Eli Lilly and Company | 2016-12-22 | 261 | 0 |
| K142518 | HumaPen Luxura | Eli Lilly and Company | 2015-06-05 | 270 | 0 |
| K100988 | HUMAPEN LUXURA HD | Eli Lilly and Company | 2010-08-17 | 130 | 0 |
| K053563 | HUMAPEN MEMOIR | Eli Lilly and Company | 2006-04-07 | 107 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda