# Eli Lilly and Company

- Location (FDA's records): Indianapolis, IN
- FDA decisions: 9 (1998–2022): 9 510(k) clearances
- Names in FDA's records: Eli Lilly and Company (5); Eli Lilly and Co. (2); Eli Lilly and Company, Inc. (2)
- Product codes: FMF (6), QOG (1), NSC (1), NDC (1)
- Predicates its devices cite: 8 (4 its own); citations of its devices by later devices: 10 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Companion Medical, Inc.: 1 (https://510kreport.com/company/companion-medical)
- Owen Mumford USA, Inc.: 1 (https://510kreport.com/company/owen-mumford-usa)
- Novo Nordisk A/S: 1 (https://510kreport.com/company/novo-nordisk-a-s)
- Dimensional Dosing Systems, Inc.: 1 (https://510kreport.com/company/dimensional-dosing-systems)

## Firms that cite its devices most
- Haselmeier GmbH: 2 (https://510kreport.com/company/haselmeier)
- Go-Pen Aps: 1 (https://510kreport.com/company/go-pen)
- Disetronic Medical Systems: 1 (https://510kreport.com/company/disetronic-medical-systems)
- Insulcloud S.L.: 1 (https://510kreport.com/company/insulcloud)
- Calibra Medical, Inc.: 1 (https://510kreport.com/company/calibra-medical)

## Its most-cited devices
- K982842: Humapen and Humapen Ergo (1998), cited by 3
- K142518: HumaPen Luxura (2015), cited by 2
- K212217: Tempo Smart Button (2022), cited by 1
- K063151: Humapen Luxura HD (2007), cited by 1
- K053563: Humapen Memoir (2006), cited by 1
- K100988: Humapen Luxura HD (2010), cited by 1

## Recent decisions
- K212217: Tempo Smart Button (Sep 16, 2022)
- K160949: Go Dose System (Dec 22, 2016)
- K160668: HumaPen Savvio (Jun 3, 2016)
- K151686: HumanPen Ergo II (Dec 30, 2015)
- K142518: HumaPen Luxura (Jun 5, 2015)
- K100988: Humapen Luxura HD (Aug 17, 2010)
- K063151: Humapen Luxura HD (Jan 9, 2007)
- K053563: Humapen Memoir (Apr 7, 2006)

Source page: https://510kreport.com/company/eli-lilly