Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Irvine Biomedical, Inc. · Predicate Candidate Screening

11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

88 daysmedian FDA review time
201 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K082061INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETERIrvine Biomedical, Inc.2008-08-19290
K060757INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETERIrvine Biomedical, Inc.2006-04-19290
K053582INQUIRY AFOCUS II DIAGNOSTIC CATHETERIrvine Biomedical, Inc.2006-03-21880
K042775INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABIrvine Biomedical, Inc.2004-11-04290
K010471AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567Irvine Biomedical, Inc.2001-06-061060
K991878LUMA-CATH STEERABLE EP CATHETERSIrvine Biomedical, Inc.1999-12-101910
K991025LUMA-CATH FIXED CURVE EP CATHETERSIrvine Biomedical, Inc.1999-10-152000
K990958ORTHOGONAL EP CATHETERSIrvine Biomedical, Inc.1999-06-03730
K982232MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATIrvine Biomedical, Inc.1998-07-25300
K961924IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEMIrvine Biomedical, Inc.1997-04-113290
K946333IBI-1000(TM) ELECTROPHYSIOLOGY CATHTERIrvine Biomedical, Inc.1995-07-182010

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda