# Disetronic Medical Systems

- Location (FDA's records): Fort Myers, FL
- FDA decisions: 29 (1991–2010): 29 510(k) clearances
- Names in FDA's records: Disetronic Medical Systems (17); Disetronic Medical Systems AG (12)
- Product codes: LZG (10), FRN (8), FMI (4), FPA (3), FMF (2), KZH (1), FRW (1)
- Predicates its devices cite: 28 (17 its own); citations of its devices by later devices: 28 (17 its own)
- Recalls linked to its devices: 40 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 4 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)
- Medtronic Minimed: 2 (https://510kreport.com/company/medtronic-minimed)
- Novo Nordisk Pharmaceuticals, Inc.: 1 (https://510kreport.com/company/novo-nordisk-pharmaceuticals)
- Minimed, Inc.: 1 (https://510kreport.com/company/minimed)
- Animas Corp.: 1 (https://510kreport.com/company/animas)
- Eli Lilly and Company: 1 (https://510kreport.com/company/eli-lilly)
- Owen Mumford USA, Inc.: 1 (https://510kreport.com/company/owen-mumford-usa)

## Firms that cite its devices most
- Roche Diagnostics Corp.: 3 (https://510kreport.com/company/roche-diagnostics)
- M2 Group Holdings, Inc.: 2 (https://510kreport.com/company/m2-group-holdings)
- Ypsomed AG: 2 (https://510kreport.com/company/ypsomed)
- Haselmeier GmbH: 2 (https://510kreport.com/company/haselmeier)
- Nipro Diabetes Systems, Inc.: 1 (https://510kreport.com/company/nipro-diabetes-systems)
- Licher Medizintechnologie GmbH: 1 (https://510kreport.com/company/licher-medizintechnologie)

## Its most-cited devices
- K973044: Disetronic H-Tron Plus V 100 Insulin Infusion Pump (1997), cited by 5
- K982966: Disetronic Pen (1998), cited by 3
- K994186: Disetronic D-Tron Insulin Infusion Pump (1999), cited by 3
- K994197: Disentronic Penfine Injection Pen Needle (1999), cited by 2
- K982399: Disetronic Penfine Injection Pen Needle (1998), cited by 2
- K021725: Disetronic D-Tron Insulin Infusion Pump (2002), cited by 1

## Recent decisions
- K100704: Accu-Chek Flexlink Plus Infusion Set, Accu-Check Linkassist Plus Insertion Device (May 14, 2010)
- K070189: Accu-Chek Ultraflex Infusion Set (Feb 21, 2007)
- K063146: Accu-Chek Linkassist (Nov 27, 2006)
- K060876: Accu-Chek Insulin Pump Configuration Software (Standard), Model 04625137001; Accu-Chek Insulin Pump Configuration Softwa (Jun 15, 2006)
- K042887: Accu-Chek Spirit (Mar 18, 2005)
- K043000: Modification to D-Tronplus (Dec 1, 2004)
- K033892: Ultraflex Infusion Set (Mar 9, 2004)
- K023471: Disetronic H-Tronplus Insulin Infusion Pump (Oct 29, 2002)

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