Disetronic Medical Systems
Fort Myers, FL, US
Disetronic Medical Systems appears in FDA device records in Fort Myers, FL. FDA records list 29 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 46 recalls for this company.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Disetronic Medical Systems carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Roche Insulin Delivery Systems Inc.recall
510(k) clearance history
FDA records hold 29 510(k) clearances for Disetronic Medical Systems between 1991 and 2010. The busiest year on record is 1999, with 5. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1992 | 2 |
| 1993 | 1 |
| 1995 | 1 |
| 1996 | 1 |
| 1997 | 3 |
| 1998 | 2 |
| 1999 | 5 |
| 2000 | 1 |
| 2001 | 2 |
| 2002 | 3 |
| 2004 | 2 |
| 2005 | 1 |
| 2006 | 2 |
| 2007 | 1 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K100704 | ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE | FRN | Substantially Equivalent | |
| K070189 | ACCU-CHEK ULTRAFLEX INFUSION SET | FPA | Substantially Equivalent | |
| K063146 | ACCU-CHEK LINKASSIST | KZH | Substantially Equivalent | |
| K060876 | ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA | LZG | Substantially Equivalent | |
| K042887 | ACCU-CHEK SPIRIT | LZG | Substantially Equivalent | |
| K043000 | MODIFICATION TO D-TRONPLUS | LZG | Substantially Equivalent | |
| K033892 | ULTRAFLEX INFUSION SET | FPA | Substantially Equivalent | |
| K023471 | DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP | LZG | Substantially Equivalent | |
| K022831 | MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP | LZG | Substantially Equivalent | |
| K021725 | DISETRONIC D-TRON INSULIN INFUSION PUMP | LZG | Substantially Equivalent | |
| K013782 | DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE | FMI | Substantially Equivalent | |
| K003977 | DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET | FPA | Substantially Equivalent | |
| K001629 | DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM | FRN | Substantially Equivalent | |
| K994186 | DISETRONIC D-TRON INSULIN INFUSION PUMP | LZG | Substantially Equivalent | |
| K994197 | DISENTRONIC PENFINE INJECTION PEN NEEDLE | FMI | Substantially Equivalent | |
| K993666 | DISETRONIC PEN P100 | FMF | Substantially Equivalent | |
| K991376 | DAHEDI INSULIN INFUSION PUMP | LZG | Substantially Equivalent | |
| K990259 | DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM | FRN | Substantially Equivalent | |
| K982966 | DISETRONIC PEN | FMF | Substantially Equivalent | |
| K982399 | DISETRONIC PENFINE INJECTION PEN NEEDLE | FMI | Substantially Equivalent | |
| K973339 | DISETRONIC PENFINE INJECTION PEN NEEDLE | FMI | Substantially Equivalent | |
| K973044 | DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP | LZG | Substantially Equivalent - Subject to Tracking Reg. | |
| K961975 | DISETRONIC D-MODEM | FRN | Substantially Equivalent - Subject to Tracking Reg. | |
| K954826 | DISETRONIC MULTIFUSE PUMP SYSTEM | FRN | Substantially Equivalent - Subject to Tracking Reg. | |
| K943952 | DISETRONIC D-MODEM | FRN | Substantially Equivalent - Subject to Tracking Reg. | |
| K920063 | DISETRONIC DOLOMAT PUMP | FRW | Substantially Equivalent | |
| K915566 | DISETRONIC PANOMAT PUMP | FRN | Substantially Equivalent | |
| K913891 | DISETRONIC(R) INFUSOR | FRN | Substantially Equivalent | |
| K905693 | H-TRON V 100 INSULIN INFUSION PUMP | LZG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
Showing 25 of 46| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1492-2011 | ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511089001. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany Manufactured for and Distributed by Roche Insulin Delivery Systems Inc. Fishers, IN 46037, USA Toll Free: 1-800-280-7801 Roche Diabetes Care AG 3401 Burgdorf, Switzerland | There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels. | Terminated | ||
| Z-1491-2011 | ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510937001. AC FLEXLINK PLUS SET 10/100 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany Manufactured for and Distributed by Roche Insulin Delivery Systems Inc. Fishers, IN 46037, USA Toll Free: 1-800-280-7801 Roche Diabetes Care AG 3401 Burgdorf, Switzerland | There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels. | Terminated | ||
| Z-1490-2011 | ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510953001. AC FLEXLINK PLUS SET 10/70 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany Manufactured for and Distributed by Roche Insulin Delivery Systems Inc. Fishers, IN 46037, USA Toll Free: 1-800-280-7801 Roche Diabetes Care AG 3401 Burgdorf, Switzerland | There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels. | Terminated | ||
| Z-1489-2011 | ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510945001. AC FLEXLINK PLUS SET 10/40 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany Manufactured for and Distributed by Roche Insulin Delivery Systems Inc. Fishers, IN 46037, USA Toll Free: 1-800-280-7801 Roche Diabetes Care AG 3401 Burgdorf, Switzerland | There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels. | Terminated | ||
| Z-1488-2011 | ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510996001. AC FLEXLINK PLUS SET 8/100 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany Manufactured for and Distributed by Roche Insulin Delivery Systems Inc. Fishers, IN 46037, USA Toll Free: 1-800-280-7801 Roche Diabetes Care AG 3401 Burgdorf, Switzerland | There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels. | Terminated | ||
| Z-1487-2011 | ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511020001. AC FLEXLINK PLUS SET 8/70 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany Manufactured for and Distributed by Roche Insulin Delivery Systems Inc. Fishers, IN 46037, USA Toll Free: 1-800-280-7801 Roche Diabetes Care AG 3401 Burgdorf, Switzerland | There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels. | Terminated | ||
| Z-1486-2011 | ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511003001. AC FLEXLINK PLUS SET 8/40 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany Manufactured for and Distributed by Roche Insulin Delivery Systems Inc. Fishers, IN 46037, USA Toll Free: 1-800-280-7801 Roche Diabetes Care AG 3401 Burgdorf, Switzerland | There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels. | Terminated | ||
| Z-1485-2011 | ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510961001. AC FLEXLINK PLUS SET 6/100 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany Manufactured for and Distributed by Roche Insulin Delivery Systems Inc. Fishers, IN 46037, USA Toll Free: 1-800-280-7801 Roche Diabetes Care AG 3401 Burgdorf, Switzerland | There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels. | Terminated | ||
| Z-1484-2011 | ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510988001. AC FLEXLINK PLUS SET 6/70 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany Manufactured for and Distributed by Roche Insulin Delivery Systems Inc. Fishers, IN 46037, USA Toll Free: 1-800-280-7801 Roche Diabetes Care AG 3401 Burgdorf, Switzerland | There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels. | Terminated | ||
| Z-1483-2011 | ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510970001. AC FLEXLINK PLUS INF 6/40 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany Manufactured for and Distributed by Roche Insulin Delivery Systems Inc. Fishers, IN 46037, USA Toll Free: 1-800-280-7801 Roche Diabetes Care AG 3401 Burgdorf, Switzerland | There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels. | Terminated | ||
| Z-1482-2011 | ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511038001. AC FLEXLINK PLUS 10MM CANNULA. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany Manufactured for and Distributed by Roche Insulin Delivery Systems Inc. Fishers, IN 46037, USA Toll Free: 1-800-280-7801 Roche Diabetes Care AG 3401 Burgdorf, Switzerland | There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels. | Terminated | ||
| Z-1481-2011 | ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511054001. AC FLEXLINK PLUS 8MM CANNULA. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany Manufactured for and Distributed by Roche Insulin Delivery Systems Inc. Fishers, IN 46037, USA Toll Free: 1-800-280-7801 Roche Diabetes Care AG 3401 Burgdorf, Switzerland | There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels. | Terminated | ||
| Z-1480-2011 | ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511046001. AC FLEXLINK PLUS 6MM CANNULA. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany Manufactured for and Distributed by Roche Insulin Delivery Systems Inc. Fishers, IN 46037, USA Toll Free: 1-800-280-7801 Roche Diabetes Care AG 3401 Burgdorf, Switzerland | There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels. | Terminated | ||
| Z-1646-2009 | Roche ACCU-CHEK Spirit insulin pump. Part numbers 4540492001, 4759702001 and 4759729001. | The "up" and "down" buttons, which are used for changing the program in the menu or to administer additional insulin through a bolus delivery, may experience intermittent failure or completely cease to operate. | Terminated | ||
| Z-1413-06 | Disetronic D-TRONplus Insulin Pump Battery Pack; Ref/Catalog no. 04697014001. | The battery may turn the pump off without warning due to a design change in the battery. | Terminated | ||
| Z-1146-06 | Disetronic Ultraflex 10/110 infusion set; (Distributed outside of the US only). | The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia | Terminated | ||
| Z-1145-06 | Disetronic Ultraflex 8/110 infusion set; (Distributed outside of the US only). | The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia | Terminated | ||
| Z-1144-06 | Disetronic Ultraflex 8/80 infusion set; Catalog number 4489039001. (Distributed outside of the US only). | The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia | Terminated | ||
| Z-1143-06 | Disetronic Ultraflex 8/60 infusion set; (Distributed outside of the US only). | The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia | Terminated | ||
| Z-1142-06 | Accu-Chek Ultraflex soft DUS 1 infusion set; 8 mm (60 cm); Catalog number 3765512001. (Distributed outside of the US only). | The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia | Terminated | ||
| Z-1141-06 | Accu-Chek Ultraflex-10 infusion set; Catalog number 454479001. | The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia | Terminated | ||
| Z-1140-06 | Accu-Chek Ultraflex-8 infusion set; Catalog number 4544773001. | The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia | Terminated | ||
| Z-1139-06 | Accu-Chek Flexlink 1 infusion set; 10 mm (110 cm); Catalog number 4540905001. (Distributed outside of the US only). | The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia | Terminated | ||
| Z-1138-06 | Accu-Chek Flexlink 1 infusion set; 10 mm (30 cm); Catalog number 4626494001. Distributed outside of the US only). | The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia | Terminated | ||
| Z-1137-06 | Accu-Chek Ultraflex-1 infusion set; 10 mm (30 cm); (Distributed outside the US only). | The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain