ClearanceBrief
510(k) K032257 ยท LZG Pump, Infusion, Insulin

MODEL IR 1200 INSULIN PUMP

ApplicantAnimas Corp., Frazer PA, US
DecisionSubstantially Equivalent, Oct 16, 2003
ReceivedJul 22, 2003
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K032257

DateFirm and productCodeLinked 510(k)
Feb 17, 2013Animas 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		 LZGNone listed
Oct 2, 2012Animas 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		 LZGNone listed
May 10, 2011Animas Corporation
2.0 mL Cartridge/Syringe Piston component of Insulin Pump Insulin infusion
Terminated		 LZGNone listed
Sep 10, 2010Animas Corporation
Animas IR 1200 Intended use:deliver insulin therapy
Terminated		 LZGNone listed
Nov 25, 2008Animas Corporation
Battery Caps used with Animas IR1200 Insulin Pump. The pump is used to help maintain blood glucose targets.
Terminated		 LZGNone listed
Dec 23, 2005Animas Corporation
Isulin Pump. Model IR1200
Terminated		 LZGNone listed
Nov 19, 2004Animas Corporation
IR 1200 Insulin Pump. IPX8 Rx only. Label P/N 400-125-00 Revision C.
Terminated		 LZGNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.