# Animas Corp.

- Location (FDA's records): Frazer, PA
- FDA decisions: 12 (2000–2014): 10 510(k) clearances and 2 original PMA approvals
- Product codes: LZG (7), MRZ (1), FPA (1), KZH (1), NCT (1), OYC (1)
- Predicates its devices cite: 10 (3 its own); citations of its devices by later devices: 9 (3 its own)
- Recalls linked to its devices: 23 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Lifescan, Inc.: 3 (https://510kreport.com/company/lifescan)
- Minimed, Inc.: 1 (https://510kreport.com/company/minimed)
- Becton, Dickinson & CO: 1 (https://510kreport.com/company/becton-dickinson)
- Insulet Corporation: 1 (https://510kreport.com/company/insulet)
- Smiths Medical MD, Inc.: 1 (https://510kreport.com/company/smiths-medical-md)

## Firms that cite its devices most
- M2 Group Holdings, Inc.: 1 (https://510kreport.com/company/m2-group-holdings)
- Collaborativemed, LLC: 1 (https://510kreport.com/company/collaborativemed)
- Disetronic Medical Systems: 1 (https://510kreport.com/company/disetronic-medical-systems)
- Nipro Diabetes Systems, Inc.: 1 (https://510kreport.com/company/nipro-diabetes-systems)
- Abbott Diabetes Care, Inc.: 1 (https://510kreport.com/company/abbott-diabetes-care)
- Lifescan, Inc.: 1 (https://510kreport.com/company/lifescan)

## Its most-cited devices
- K042873: Animas Model IR1250 Insulin Infusion Pump (2004), cited by 3
- K032257: Model IR 1200 Insulin Pump (2003), cited by 2
- K080639: Symphony Glucose Management System (2008), cited by 2
- K063674: Ezmanager Max Diabetes Management Software (2007), cited by 1
- K022394: Ezmanager Plus (2003), cited by 1

## Recent decisions
- P130007: Animas Vibe System (Nov 25, 2014)
- K080639: Symphony Glucose Management System (Jun 24, 2008)
- K080587: EZ Manager Max Diabetes Management Software (May 15, 2008)
- K063674: Ezmanager Max Diabetes Management Software (Mar 30, 2007)
- K042873: Animas Model IR1250 Insulin Infusion Pump (Dec 10, 2004)
- K032257: Model IR 1200 Insulin Pump (Oct 16, 2003)
- K022394: Ezmanager Plus (Jun 5, 2003)
- K021700: Animus Ezserter Infusion Set Inserter (Jun 4, 2002)

Source page: https://510kreport.com/company/animas