Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

NLH — Predicate Candidate Screening

70 FDA 510(k) clearances under this product code; the 50 most recent screened below.

133 daysmedian FDA review time
351 days90th percentile
70clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252405Medline ReNewal Reprocessed Boston Scientific Dynamic Tip UnSurgical Instrument Service and Savings, Inc.2025-11-261180
K250772Medline ReNewal Reprocessed Boston Scientific Dynamic XT UniSurgical Instrument Service and Savings, Inc.2025-07-111200
K242225Medline ReNewal Reprocessed Abbott Inquiry Steerable DiagnosSurgical Instrument Service and Savings, Inc.2024-11-291232
K241224Medline ReNewal Reprocessed Biosense Webster Webster CS CathSurgical Instrument Service and Savings Inc.(Dba Medline Ren2024-11-151972
K240826Reprocessed DECANAV™ Electrophysiology Catheter; ReprocessedSterilmed, Inc.2024-10-111990
K241156Medline ReNewal Reprocessed St. Jude Medical Response ElectrSurgical Instrument Service and Savings, Inc.2024-09-141413
K233825Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterInnovative Health2024-06-071890
K240972Medline ReNewal Reprocessed Medtronic Achieve Catheter ConneSurgical Instrument Service and Savings, Inc.2024-06-07590
K221067Medline ReNewal Reprocessed St. Jude Medical Livewire SteeraSurgical Instrument Service and Savings, Inc.2023-05-314143
K221854Reprocesses Umbilical CableInnovative Health, LLC2022-08-06400
K211276Reprocessed Dynamic Tip and XT Steerable Diagnostic ElectropInnovative Health, LLC2021-09-151410
K203655Reprocessed Webster CS Bi-Directional Diagnostic EP CatheterInnovative Health, LLC2021-05-041400
K200205Reprocessed Advisor FL Circular Mapping Catheter, Sensor EnaStryker Sustainability Solutions2020-05-131060
K193263Reprocessed Achieve Catheter Connecting CableInnovative Health, LLC2020-01-24590
K191170Reprocessed Reflexion Spiral Bi-Directional Variable Radius Innovative Health, LLC2019-10-301820
K190127Reprocessed Livewire Steerable Diagnostic Electrophysiology Innovative Health, LLC2019-08-232070
K182488Reprocessed Response Diagnostic Electrophysiology CatheterInnovative Health, LLC2019-02-221640
K181056Reprocessed CS Diagnostic Electrophysiology CatheterStryker Sustainability Solutions2019-01-242790
K181897Reprocessed Marinr Diagnostic EP CatheterInnovative Health, LLC2018-11-151220
K181458Reprocessed Advisor FL Sensor Enabled Circular Mapping CatheInnovative Health, LLC2018-10-271450
K181618Reprocessed Torqr Diagnostic EP CatheterInnovative Health, LLC2018-10-181210
K180710Reprocessed DecaNav Diagnostic Electrophysiology CatheterInnovative Health, LLC2018-06-19920
K171788Reprocessed Halo XP Diagnostic Electrophysiology CatheterInnovative Health, LLC2017-11-031410
K171503Reprocessed CristaCath Diagnostic Electrophysiology CatheterInnovative Health, LLC2017-10-051350
K170922Reprocessed Webster CS Bi-Directional Diagnostic EP CatheterInnovative Health, LLC2017-06-22850
K161272Supreme and Response Electrophysiology CathetersSurgical Instrument Service and Savings, Inc.2017-05-183780
K162251Reprocessed Viking Diagnostic Electrophysiology CathetersInnovative Health, LLC2016-12-211330
K161827Reprocessed Response Diagnostic Electrophysiology CathetersInnovative Health, LLC2016-12-081560
K160421Reprocessed Inquiry Optima Plus Steerable Diagnostic EP CathInnovative Health, LLC2016-11-022600
K161393Reprocessed Orbiter ST Steerable Diagnostic EP CatheterInnovative Health, LLC2016-10-261600
K161464Reprocessed Dynamic Tip Steerable Diagnostic ElectrophysioloInnovative Health, LLC2016-09-301270
K153006Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable ElSterilmed, Inc.2016-06-232530
K160496Reprocessed Inquiry Steerable Diagnostic EP CatheterInnovative Health, LLC2016-06-101090
K160242Reprocessed Livewire Steerable Diagnostic EP CatheterInnovative Health, LLC2016-05-10990
K160303Reprocessed Polaris X Steerable Diagnostic EP CatheterInnovative Health, LLC2016-05-10960
K153153Reprocessed Electrophysiology CatheterInnovative Health, LLC2016-03-141330
K151617Livewire Electrophysiology CatheterSurgical Instrument Service and Savings Inc.(Dba Medline Ren2016-01-222210
K150357Reprocessed Electrophysiology Diagnostic CathetersSterilmed, Inc.2015-08-271960
K121158REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERSSterilmed, Inc.2012-08-061120
K112292REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETERStryker Sustainability Solutions2011-10-21721
K112232REPROCESSED ELECTROPHYSIOLOGY CATHETERSStryker Sustainability Solutions2011-09-26530
K101789REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERSSterilmed, Inc.2010-08-19520
K100254REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CAAscent Healthcare Solutions2010-05-2812026
K092158REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERSSterilmed, Inc.2010-01-141820
K090323REPROCESSED ELECTROPHYSIOLOGY CATHETERSAscent Healthcare Solutions2009-04-01510
K082023REPROCESSED ELECTROPHYSIOLOGY CATHETERSAscent Healthcare Solutions2008-09-16620
K081329REPROCESSED ELECTROPHYSIOLOGY CATHETERSAscent Healthcare Solutions2008-07-09580
K061045REPROCESSED ELECTROPHYSIOLOGY CATHETERSAlliance Medical Corp.2006-08-311390
K052414REPROCESSED ELECTROPHYSIOLOGY CATHETERAlliance Medical Corp.2005-11-16750
K052603REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERSAlliance Medical Corp.2005-11-165626

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