Animas Corporation
Medical device manufacturer in Wayne, PA.
10510(k) clearances
2PMA approvals
22recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K080639 | Symphony Glucose Management SystemLZG · Traditional | 06/24/2008SE |
| K080587 | Ez Manager Max Diabetes Management SoftwareMRZ · Traditional | 05/15/2008SE |
| K063674 | Ezmanager Max Diabetes Management SoftwareLZG · Traditional | 03/30/2007SE |
| K042873 | Animas Model IR1250 Insulin Infusion PumpLZG · Traditional | 12/10/2004SE |
| K032257 | Model Ir 1200 Insulin PumpLZG · Traditional | 10/16/2003SE |
| K022394 | Ezmanager PlusLZG · Traditional | 06/05/2003SE |
| K021700 | Animus Ezserter Infusion Set InserterKZH · Traditional | 06/04/2002SE |
| K021439 | Model R1000 Ir Insulin Pump, Ezlink Software, Sermon Software, R1000 Ir Download Cradle…LZG · Special | 05/29/2002SE |
| K012754 | Ez Set Infusion SetFPA · Traditional | 08/27/2001SE |
| K993184 | R1000 Series Insulin PumpLZG · Traditional | 02/10/2000SE |
PMA approvals
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0136-2015 Class II | Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous…Animas determined that the Hebrew language translation in the Vibe Insulin Infusion Pump was incorrect and… | 06/10/2014Terminated |
| Z-0993-2013 Class I | Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for…Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pumps. The… | 01/03/2013Terminated |
| Z-0836-2013 Class III | Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps…Due to an internal calendar date limit (December 31, 2015) these pumps will cease to operate on January 1… | 12/17/2012Terminated |
| Z-0137-2015 Class II | Animas Vibe Insulin Infusion Pump and System. These products are indicated for…Animas determined that keypad wear over time was contributing to an increased complaint rate associated with… | 10/25/2012Terminated |
| Z-0005-2013 Class II | IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose…Wear of the keypad that may lead to damage such as tearing or peeling of the edge of the keypad from the pump. | 07/16/2012Terminated |
| Z-1376-2012 | OneTouch(R) Ping(R) Insulin Pump glucose management system. The device is intended to…There is an error in the pump software where the OneTouch(R) Ping(R) insulin pump did not allow the user to… | 03/01/2012Terminated |
| Z-1034-2015 Class II | Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous…Calibration factors in the pump overwritten during a programming step. The force sensor could send a lower… | 09/06/2011Terminated |
| Z-3017-2011 | Animas 2020 Insulin Infusion Pump. Animas Corp. An insulin infusion.Incorrect component (1nF capacitor) was used to produce 191 printed circuit boards used in six pump lots of… | 07/29/2011Terminated |
| Z-1678-2011 | 2.0 mL Cartridge/Syringe Piston component of Insulin Pump Insulin infusionAction is being undertaken to address the occurrence of adverse events associated with leaking cartridges.… | 02/25/2011Terminated |
| Z-2397-2010 | Animas IR 1250 (1200 plus) Intended use:deliver insulin therapysensor could be damaged | 03/18/2010Terminated |
| Z-2396-2010 | Animas IR 1200 Intended use:deliver insulin therapysensor could be damaged | 03/18/2010Terminated |
| Z-2395-2010 | Animas 2020 Insulin Infusion Pumps Intended use:deliver insulin therapysensor could be damaged | 03/18/2010Terminated |
| Z-2394-2010 | One Touch Ping Glucose Management Systems Intended use: deliver insulin therapysensor could be damaged | 03/18/2010Terminated |
| Z-1560-2010 | One Touch Ping Insulin Pump using ezManager Max diabetes management softwareSoftware malfunction which disallows users to download, view and print information from their pump… | 12/18/2009Terminated |
| Z-0481-2010 | Animas ezManager Max Diabetes Management System version 2.0.9Printed hard copy of results is not the same as the system screens- carbohydrate to insulin ratio incorrect. | 11/02/2009Terminated |
| Z-0955-2009 | Meter Remote for OneTouch Ping Glucose Management Systemincorrect dosing recommendation | 10/27/2008Terminated |
| Z-0294-2009 | Battery Caps used with Animas IR1250 Insulin Pump. The pump is used to help maintain…Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of… | 08/04/2008Terminated |
| Z-0293-2009 | Battery Caps used with Animas IR1200 Insulin Pump. The pump is used to help maintain…Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of… | 08/04/2008Terminated |
| Z-0292-2009 | Battery Caps used with Animas 2020 Insulin Pump. The pump is used to help maintain blood…Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of… | 08/04/2008Terminated |
| Z-0291-2009 | Battery Caps used with OneTouch Ping Glucose Monitoring System. The pump is used to help…Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of… | 08/04/2008Terminated |
| Z-0290-2009 | Battery Caps used with insulin pumps and glucose monitoring systems. The pump is used to…Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of… | 08/04/2008Terminated |
| Z-0283-2009 | One Touch Ping Glucose Monitoring System Combines the functionality of OneTouch(R) Ping…display old, inaccurate values for bolus amount delivered and amount of planned bolus totals | 08/04/2008Terminated |