# Companion Medical, Inc.

- Location (FDA's records): San Diego, CA
- FDA decisions: 5 (2016–2020): 5 510(k) clearances
- Product codes: NDC (4), FMF (1)
- 510(k) review time since 2016: median 130 days, against 53 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 6 (4 its own); citations of its devices by later devices: 10 (4 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Novo Nordisk, Inc.: 1 (https://510kreport.com/company/novo-nordisk)
- Roche Diabetes Care, Inc.: 1 (https://510kreport.com/company/roche-diabetes-care)

## Firms that cite its devices most
- Eli Lilly and Company: 1 (https://510kreport.com/company/eli-lilly)
- Tandem Diabetes Care, Inc.: 1 (https://510kreport.com/company/tandem-diabetes-care)
- Voluntis Sa.: 1 (https://510kreport.com/company/voluntis)
- Comerge AG: 1 (https://510kreport.com/company/comerge)
- Medtronic Minimed: 1 (https://510kreport.com/company/medtronic-minimed)
- Biocorp Production: 1 (https://510kreport.com/company/biocorp-production)

## Its most-cited devices
- K160629: InPen (2016), cited by 5
- K190487: InPen Dose Calculator (2020), cited by 3
- K181327: InPen Dose Calculator (2018), cited by 1
- K201337: InPen System (2020), cited by 1

## Recent decisions
- K201337: InPen System (Jun 18, 2020)
- K190487: InPen Dose Calculator (Feb 18, 2020)
- K192841: InPen System (Feb 10, 2020)
- K181327: InPen Dose Calculator (Jul 6, 2018)
- K160629: InPen (Jul 26, 2016)

Source page: https://510kreport.com/company/companion-medical