Company ยท US
Disetronic Medical Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2010. Name variants (Inc, Corp, punctuation) are merged.
29510(k) clearances (0 in 12 months)
33recalls (0 in 12 months)
14recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 14, 2010 | K100704 | ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE Disetronic Medical Systems AG | FRN |
| Feb 21, 2007 | K070189 | ACCU-CHEK ULTRAFLEX INFUSION SET Disetronic Medical Systems AG | FPA |
| Nov 27, 2006 | K063146 | ACCU-CHEK LINKASSIST Disetronic Medical Systems AG | KZH |
| Jun 15, 2006 | K060876 | ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA Disetronic Medical Systems AG | LZG |
| Mar 18, 2005 | K042887 | ACCU-CHEK SPIRIT Disetronic Medical Systems AG, CH | LZG |
| Dec 1, 2004 | K043000 | MODIFICATION TO D-TRONPLUS Disetronic Medical Systems AG | LZG |
| Mar 9, 2004 | K033892 | ULTRAFLEX INFUSION SET Disetronic Medical Systems AG, SE | FPA |
| Oct 29, 2002 | K023471 | DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP Disetronic Medical Systems AG | LZG |
| Sep 11, 2002 | K022831 | MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP Disetronic Medical Systems AG, SE | LZG |
| Aug 2, 2002 | K021725 | DISETRONIC D-TRON INSULIN INFUSION PUMP Disetronic Medical Systems AG, CH | LZG |
| Nov 20, 2001 | K013782 | DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE Disetronic Medical Systems | FMI |
| Feb 15, 2001 | K003977 | DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET Disetronic Medical Systems AG | FPA |
| Jun 21, 2000 | K001629 | DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM Disetronic Medical Systems AG | FRN |
| Dec 30, 1999 | K994186 | DISETRONIC D-TRON INSULIN INFUSION PUMP Disetronic Medical Systems | LZG |
| Dec 29, 1999 | K994197 | DISENTRONIC PENFINE INJECTION PEN NEEDLE Disetronic Medical Systems | FMI |
| Nov 22, 1999 | K993666 | DISETRONIC PEN P100 Disetronic Medical Systems | FMF |
| Jun 15, 1999 | K991376 | DAHEDI INSULIN INFUSION PUMP Disetronic Medical Systems | LZG |
| Feb 12, 1999 | K990259 | DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM Disetronic Medical Systems | FRN |
| Oct 19, 1998 | K982966 | DISETRONIC PEN Disetronic Medical Systems | FMF |
| Aug 6, 1998 | K982399 | DISETRONIC PENFINE INJECTION PEN NEEDLE Disetronic Medical Systems | FMI |
| Sep 24, 1997 | K973339 | DISETRONIC PENFINE INJECTION PEN NEEDLE Disetronic Medical Systems | FMI |
| Sep 15, 1997 | K973044 | DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP Disetronic Medical Systems | LZG |
| Jan 30, 1997 | K961975 | DISETRONIC D-MODEM Disetronic Medical Systems | FRN |
| May 24, 1996 | K954826 | DISETRONIC MULTIFUSE PUMP SYSTEM Disetronic Medical Systems | FRN |
| Oct 7, 1995 | K943952 | DISETRONIC D-MODEM Disetronic Medical Systems | FRN |
| Aug 3, 1993 | K920063 | DISETRONIC DOLOMAT PUMP Disetronic Medical Systems | FRW |
| Aug 7, 1992 | K915566 | DISETRONIC PANOMAT PUMP Disetronic Medical Systems | FRN |
| Mar 27, 1992 | K913891 | DISETRONIC(R) INFUSOR Disetronic Medical Systems | FRN |
| Apr 12, 1991 | K905693 | H-TRON V 100 INSULIN INFUSION PUMP Disetronic Medical Systems | LZG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 26, 2009 | Disetronic Medical Systems, Inc. Roche ACCU-CHEK Spirit insulin pump. Part numbers 4540492001, 4759702001 and 4759729001. Terminated |
LZG | K060876 |
| Sep 12, 2006 | Disetronic Medical Systems, Inc. Disetronic D-TRONplus Insulin Pump Battery Pack; Ref/Catalog no. 04697014001. Terminated |
LZG | K043000 |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Disetronic Ultraflex 10/110 infusion set; (Distributed outside of the US only). Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Disetronic Ultraflex 8/110 infusion set; (Distributed outside of the US only). Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Disetronic Ultraflex 8/80 infusion set; Catalog number 4489039001. (Distributed outside of the US only). Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Disetronic Ultraflex 8/60 infusion set; (Distributed outside of the US only). Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Ultraflex soft DUS 1 infusion set; 8 mm (60 cm); Catalog number 3765512001. (Distributed outside of the US only). Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-10 infusion set; Catalog number 454479001. Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-8 infusion set; Catalog number 4544773001. Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Flexlink 1 infusion set; 10 mm (110 cm); Catalog number 4540905001. (Distributed outside of the US only). Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Flexlink 1 infusion set; 10 mm (30 cm); Catalog number 4626494001. Distributed outside of the US only). Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-1 infusion set; 10 mm (30 cm); (Distributed outside the US only). Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-1 infusion set; 8 mm (30 cm); (Distributed outside the US only). Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek FlexLink Cannula 10; Ref number 04541227001. (Distributed outside of the U.S. only). Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek FlexLink Cannula 8; Ref number 04541219001. (Distributed outside of the U.S. only). Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek FlexLink 1 infusion set; 10/80; Ref number 04540891001. (Distributed outside of the U.S. only). Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek FlexLink 1 infusion set; 10/60; Ref number 04540875001. (Distributed outside of the U.S. only). Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek FlexLink 1 infusion set; 8/110; Ref number 04540832001. (Distributed outside of the U.S. only). Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek FlexLink 1 infusion set; 8/80; Ref number 04540816001. (Distributed outside of the U.S. only). Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek FlexLink 1 infusion set; 8/60; Ref number 04540794001. (Distributed outside of the U.S. only). Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek FlexLink 1 infusion set; 8/30; Ref number 04540778001. (Distributed outside of the U.S. only). Terminated |
LZG | None listed |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-2 infusion set; 10 mm 43'' (110 cm); Catalog number INF 04540972001. Terminated |
LZG | K033892 |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-2 infusion set; 10 mm 31'' (80 cm); Catalog number INF 04540964001. Terminated |
LZG | K033892 |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-2 infusion set; 10 mm 24'' (60 cm); Catalog number INF 04540956001. Terminated |
LZG | K033892 |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-2 infusion set; 8 mm 43'' (110 cm); Catalog number INF 04540948001. Terminated |
LZG | K033892 |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-2 infusion set; 8 mm 31'' (80 cm); Catalog number INF 04540930001. Terminated |
LZG | K033892 |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-2 infusion set; 8 mm 24'' (60 cm); Catalog number INF 04540921001. Terminated |
LZG | K033892 |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-1 infusion set; 10 mm 43'' (110 cm); Catalog number INF 04540905001. Terminated |
LZG | K033892 |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-1 infusion set; 10 mm 31'' (80 cm); Catalog number INF 04540883001 (Distributed U.S. and Canada) and Ref. No 04626524001 (Distributed outside of the the U.S. only). Terminated |
LZG | K033892 |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-1 infusion set; 10 mm 24'' (60 cm); Catalog number INF 04540867001. Terminated |
LZG | K033892 |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-1 infusion set; 8 mm 43'' (110 cm); Catalog number INF 04540824001. Terminated |
LZG | K033892 |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-1 infusion set; 8 mm 31'' (80 cm); Catalog number INF 04540808001 (Distributed U.S. and Canada) and Ref No. 04626478001 (Distributed outside the U.S. only). Terminated |
LZG | K033892 |
| Jul 8, 2006 | Disetronic Medical Systems, Inc. Accu-Chek Ultraflex 1-infusion set; 8 mm 24'' (60 cm); Catalog Number INF 04540786001. Terminated |
LZG | K033892 |