Company ยท US
Animas Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2008. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
28recalls (0 in 12 months)
22recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 24, 2008 | K080639 | SYMPHONY GLUCOSE MANAGEMENT SYSTEM Animas Corp. | LZG |
| May 15, 2008 | K080587 | EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE Animas Corp. | MRZ |
| Mar 30, 2007 | K063674 | EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE Animas Corp. | LZG |
| Dec 10, 2004 | K042873 | ANIMAS MODEL IR1250 INSULIN INFUSION PUMP Animas Corp. | LZG |
| Oct 16, 2003 | K032257 | MODEL IR 1200 INSULIN PUMP Animas Corp. | LZG |
| Jun 5, 2003 | K022394 | EZMANAGER PLUS Animas Corp. | LZG |
| Jun 4, 2002 | K021700 | ANIMUS EZSERTER INFUSION SET INSERTER Animas Corp. | KZH |
| May 29, 2002 | K021439 | MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO Animas Corp. | LZG |
| Aug 27, 2001 | K012754 | EZ SET INFUSION SET Animas Corp. | FPA |
| Feb 10, 2000 | K993184 | R1000 SERIES INSULIN PUMP Animas Corp. | LZG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2015 | Animas Corporation Animas Vibe Insulin Infusion Pump.
This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature. Terminated |
OYC | None listed |
| Oct 24, 2014 | Animas Corporation Animas Vibe Insulin Infusion Pump and System.
These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes. Terminated |
LZG | None listed |
| Oct 24, 2014 | Animas Corporation Animas Vibe Insulin Infusion Pump.
This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature. Terminated |
N/A | None listed |
| Apr 3, 2013 | Animas Corporation Animas(R) 2020 Insulin Infusion Pump
Product Usage:
This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes. Terminated |
LZG | K042873 |
| Feb 17, 2013 | Animas Corporation Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps
Indicated for continuous subcutaneous infusion of insulin. Terminated |
LZG | K032257 K042873 |
| Oct 2, 2012 | Animas Corporation IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system.
The device is intended to deliver insulin therapy. Terminated |
LZG | K032257 |
| Apr 6, 2012 | Animas Corporation OneTouch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy. Terminated |
LZG | K080639 |
| Aug 12, 2011 | Animas Corporation Animas 2020 Insulin Infusion Pump.
Animas Corp.
An insulin infusion. Terminated |
LZG | None listed |
| May 10, 2011 | Animas Corporation 2.0 mL Cartridge/Syringe Piston component of Insulin Pump
Insulin infusion Terminated |
LZG | K032257 |
| Sep 10, 2010 | Animas Corporation Animas IR 1250 (1200 plus)
Intended use:deliver insulin therapy Terminated |
LZG | None listed |
| Sep 10, 2010 | Animas Corporation Animas IR 1200
Intended use:deliver insulin therapy Terminated |
LZG | K032257 |
| Sep 10, 2010 | Animas Corporation Animas 2020 Insulin Infusion Pumps
Intended use:deliver insulin therapy Terminated |
LZG | None listed |
| Sep 10, 2010 | Animas Corporation One Touch Ping Glucose Management Systems
Intended use: deliver insulin therapy Terminated |
LZG | K080639 |
| May 8, 2010 | Animas Corporation One Touch Ping Insulin Pump using ezManager Max diabetes management software Terminated |
LZG | K080639 |
| Dec 3, 2009 | Animas Corporation Animas ezManager Max Diabetes Management System version 2.0.9 Terminated |
MRZ | K080587 |
| Mar 3, 2009 | Animas Corporation Meter Remote for OneTouch Ping Glucose Management System Terminated |
LZG | K080639 |
| Nov 25, 2008 | Animas Corporation Battery Caps used with Animas IR1250 Insulin Pump.
The pump is used to help maintain blood glucose targets. Terminated |
LZG | K042873 |
| Nov 25, 2008 | Animas Corporation Battery Caps used with Animas IR1200 Insulin Pump.
The pump is used to help maintain blood glucose targets. Terminated |
LZG | K032257 |
| Nov 25, 2008 | Animas Corporation Battery Caps used with Animas 2020 Insulin Pump.
The pump is used to help maintain blood glucose targets. Terminated |
LZG | K042873 |
| Nov 25, 2008 | Animas Corporation Battery Caps used with OneTouch Ping Glucose Monitoring System.
The pump is used to help maintain blood glucose targets. Terminated |
LZG | K080639 |
| Nov 25, 2008 | Animas Corporation Battery Caps used with insulin pumps and glucose monitoring systems.
The pump is used to help maintain blood glucose targets. Terminated |
LZG | K080639 |
| Nov 7, 2008 | Animas Corporation One Touch Ping Glucose Monitoring System
Combines the functionality of OneTouch(R) Ping (TM) Insulin Pump and a OneTouch(R) Ping (TM) Meter Remote through radio frequency (RF) communication. Togethe Terminated |
LZG | K080639 |
| Dec 23, 2005 | Animas Corporation Isulin Pump. Model IR1250 Terminated |
LZG | K042873 |
| Dec 23, 2005 | Animas Corporation Isulin Pump. Model IR1200 Terminated |
LZG | K032257 |
| Dec 23, 2005 | Animas Corporation Isulin Pump. Model IR1000 Terminated |
LZG | K021439 |
| Dec 23, 2005 | Animas Corporation Isulin Pump. Models R1000 Terminated |
LZG | K993184 |
| Jun 25, 2005 | Animas Corporation Animas IR 1250 Insulin Pump. Terminated |
LZG | K042873 |
| Nov 19, 2004 | Animas Corporation IR 1200 Insulin Pump. IPX8 Rx only. Label P/N 400-125-00 Revision C. Terminated |
LZG | K032257 |