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Data / Medical devices / United States / Irvine Biomedical. Inc.

Irvine Biomedical. Inc.: FDA-registered device maker in Irvine, CA, United States, 20 510(k) clearances and 4 PMA approvals

Irvine Biomedical. Inc. is registered with the FDA (registration 2030404) in Irvine, CA, United States. It lists 9 device types. The FDA files 20 510(k) clearances and 4 PMA approvals under its listings, the newest dated May 23, 2025. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Irvine Biomedical. Inc.
FDA registration number
2030404
FEI number
1000519796
Address
2375 Morse Ave, Irvine, CA, United States, 92614
Owner or operator
ABBOTT LABORATORIES (1415939)
Roles
Manufacturer, Manufacturer for export, Specification developer
First device listed
December 7, 2007
Registered through
2027
Brand names listed
Advisor FL Mapping Catheter, Sensor Enabled Software Installation, Advisor FL Mapping Catheter, Sensor Enabled Software Installation, H702507, Advisor HD Grid Mapping Catheter, Sensor Enbled Software Installation, Advisor HD Grid Mapping Catheter, Sensor Enbled Software Installation, H702519, Advisor HD/VL Mapping Catheter, Catheter Catalog Installation Sensor Enabled, Advisor HD/VL Mapping Catheter, Catheter Catalog Installation Sensor Enabled, H702532, Advisor HD™ Grid High Density Mapping Catheter, Sensor Enabled™, D-AVHD-DF16, Advisor™ FL Circular Mapping Catheter, Sensor Enabled™, D-AVSE-D10-F15 and more

Devices it lists

DeviceProduct codeClassRoleSource
Cable, ElectrodeIKD2Manufacturer, Manufacturer for export, Specification developeraccessdata.fda.gov
Cardiac Ablation Percutaneous CatheterLPB3Manufacturer, Manufacturer for export, Specification developeraccessdata.fda.gov
Catheter, Electrode Recording, Or Probe, Electrode RecordingDRF2Manufacturer, Manufacturer for export, Specification developeraccessdata.fda.gov
Catheter, Intracardiac Mapping, High-Density ArrayMTD2Manufacturer, Specification developeraccessdata.fda.gov
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FlutterOAD3Manufacturer, Manufacturer for export, Specification developeraccessdata.fda.gov
Catheter, Ultrasound, IntravascularOBJ2Manufacturer, Specification developeraccessdata.fda.gov
Computer, Diagnostic, ProgrammableDQK2Manufactureraccessdata.fda.gov
Introducer, CatheterDYB2Manufacturer, Specification developeraccessdata.fda.gov
Reprocessed Intravascular Ultrasound CatheterOWQ2Manufacturer, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 23, 2025K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™OBJSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
May 20, 2025K251231ViewFlex™ X ICE Catheter, Sensor Enabled™OBJSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
August 9, 2024K242016EnSite™ X EP SystemDQKSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
August 10, 2023K231415EnSite™ X EP SystemDQKSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
December 27, 2022K223094EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade; EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software LicenseDQKSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
December 7, 2022K223077ViewFlex Xtra ICE CatheterOBJSubstantially EquivalentIrvine Biomedical, A St. Jude Medical Companyaccessdata.fda.gov
August 18, 2022K221213EnSite X EP SystemDQKSubstantially EquivalentAbbottaccessdata.fda.gov
November 11, 2021K213364EnSite X EP SystemDQKSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
October 22, 2021K212061EnSite X EP SystemDQKSubstantially EquivalentAbbottaccessdata.fda.gov
November 25, 2020K202066EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor EnabledDQKSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
June 26, 2020K201181EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping SystemDQKSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
December 12, 2018K183128EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2DQKSubstantially EquivalentAbbottaccessdata.fda.gov
May 19, 2014K133853VIEWFLEX XTRA ICE CATHETEROBJSubstantially EquivalentIrvine Biomedical, Inc., A St. Jude Medical Companyaccessdata.fda.gov
August 13, 2010K101623INQUIRY AFOCUSII DIAGNOSTIC CATHETERDRFSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
April 19, 2006K060757INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETERDRFSubstantially EquivalentIrvine Biomedical, Inc.accessdata.fda.gov
November 4, 2004K042775INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETERDRFSubstantially EquivalentIrvine Biomedical, Inc.accessdata.fda.gov
June 6, 2001K010471AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569DRFSubstantially EquivalentIrvine Biomedical, Inc.accessdata.fda.gov
December 10, 1999K991878LUMA-CATH STEERABLE EP CATHETERSDRFSubstantially EquivalentIrvine Biomedical, Inc.accessdata.fda.gov
July 25, 1998K982232MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEMDRFSubstantially EquivalentIrvine Biomedical, Inc.accessdata.fda.gov
April 11, 1997K961924IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEMDRFSubstantially EquivalentIrvine Biomedical, Inc.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
January 25, 2012P110016THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOROAD91August 7, 2026accessdata.fda.gov
March 16, 2007P060019IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RFOAD55August 7, 2026accessdata.fda.gov
November 18, 2005P040042THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETEROAD57September 3, 2026accessdata.fda.gov
January 14, 2005P040014IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATORLPB50September 3, 2026accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
August 24, 202086328Class IITerminatedInquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation duriSteerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model IBI-87002, batch 7397307. Packages labeled Model IBI-87002, batch 7397307 incorrectly contained Model IBI-81104, batch 7397352.If physicians fail to observe the catheter difference, the intracardiac electrograms will not be representative of the desired accessdata.fda.gov

Compare with other makers

Updated August 7, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.