ClearanceBrief
510(k) K030429 ยท MLR Sterilizer, Chemical

STERRAD 200 STERILIZER

ApplicantAdvanced Sterilization Products, Irvin CA, US
DecisionSubstantially Equivalent, Aug 18, 2003
ReceivedFeb 10, 2003
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K030429

DateFirm and productCodeLinked 510(k)
Dec 22, 2014Advanced Sterilization Products
STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reus
Terminated		 MLRNone listed
Oct 22, 2013Advanced Sterilization Products
STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer us
Terminated		 MLRNone listed
Mar 30, 2013Advanced Sterilization Products
STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 200 process to inactivate micro
Terminated		 MLRNone listed
Mar 26, 2013Advanced Sterilization Products
STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer.
Terminated		 MLRNone listed
Jan 13, 2012Advanced Sterilization Products
STERRAD 200 Sterilizer, Hydrogen Peroxide Gas Plasma Sterilizer, Chemical Sterilizer. STERRAD 200; Product Usage: The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used
Terminated		 MLRNone listed
Aug 8, 2008Advanced Sterilization Products
STERRAD 200 Sterilization System, Product Code 10201 Used to sterilize heat and moisture sensitive reusable medical devices.
Terminated		 MLRNone listed
Feb 8, 2008Advanced Sterilization Products
STERRAD 100S Sterilizer, Product Code: 10101, Advanced Sterilization Products, Irvine, CA
Terminated		 MLRNone listed
Feb 7, 2008Advanced Sterilization Products
STERRAD Sterilizers ( Models 100S, 50, 200) Compatible Medical Device Reference List for US Customers, Document Numbers 15-53229 & 15-53230; STERRAD NX Sterilizers Compatible Medical Device Reference
Terminated		 MLRNone listed

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