Atlas FDA

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

Innovative Health, LLC — Predicate Candidate Screening

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

145 daysmedian FDA review time
268 days90th percentile
48clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K231015Reprocessed Super Torque and Super Torque Plus Diagnostic AnInnovative Health, LLC2024-07-014480
K232037Reprocessed VersaCross Steerable Sheath; Reprocessed SureFleInnovative Health, LLC2024-04-042690
K230376Reprocessed Agilis NxT Steerable IntroducerInnovative Health, LLC2023-08-071750
K213584Reprocessed NRG Transseptal NeedleInnovative Health, LLC2023-04-045080
K221854Reprocesses Umbilical CableInnovative Health, LLC2022-08-06400
K210655Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterInnovative Health, LLC2022-05-254470
K212165Reprocessed Carto Vizigo Bi-Directional Guiding SheathInnovative Health, LLC2022-03-102410
K212776Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledInnovative Health, LLC2021-12-201100
K211662Reprocessed IntellaMap Orion High Resolution Mapping CatheteInnovative Health, LLC2021-11-181700
K211276Reprocessed Dynamic Tip and XT Steerable Diagnostic ElectropInnovative Health, LLC2021-09-151410
K203655Reprocessed Webster CS Bi-Directional Diagnostic EP CatheterInnovative Health, LLC2021-05-041400
K203261Reprocessed Inquiry Steerable Diagnostic EP CatheterInnovative Health, LLC2021-03-051200
K202042Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound CatheterInnovative Health, LLC2020-11-201200
K200212Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledInnovative Health, LLC2020-09-032190
K200060Reprocessed NRG Transseptal NeedleInnovative Health, LLC2020-07-301990
K192998Reprocessed BRK Transseptal NeedleInnovative Health, LLC2020-07-222680
K193263Reprocessed Achieve Catheter Connecting CableInnovative Health, LLC2020-01-24590
K191880Reprocessed Achieve Advance Mapping Diagnostic ElectrophysioInnovative Health, LLC2019-12-111490
K191170Reprocessed Reflexion Spiral Bi-Directional Variable Radius Innovative Health, LLC2019-10-301820
K190127Reprocessed Livewire Steerable Diagnostic Electrophysiology Innovative Health, LLC2019-08-232070
K190980Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterInnovative Health, LLC2019-07-01770
K190785Reprocessed PentaRay Nav eco High-Density Mapping CatheterInnovative Health, LLC2019-06-25900
K182386Reprocessed Supreme Diagnostic Electrophysiology CatheterInnovative Health, LLC2019-04-232310
K182488Reprocessed Response Diagnostic Electrophysiology CatheterInnovative Health, LLC2019-02-221640
K181126Reprocessed Visions PV .035 Digital IVUS CatheterInnovative Health, LLC2019-01-182630
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
K173262Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound CatheterInnovative Health, LLC2018-03-061460
K171788Reprocessed Halo XP Diagnostic Electrophysiology CatheterInnovative Health, LLC2017-11-031410
K171277Reprocessed Inquiry Steerable Diagnostic EP CatheterInnovative Health, LLC2017-10-231750
K171503Reprocessed CristaCath Diagnostic Electrophysiology CatheterInnovative Health, LLC2017-10-051350
K163560Reprocessed AcuNav Diagnostic Ultrasound CatheterInnovative Health, LLC2017-07-122050
K170922Reprocessed Webster CS Bi-Directional Diagnostic EP CatheterInnovative Health, LLC2017-06-22850
K170474Reprocessed SoundStar 3D Diagnostic Ultrasound CatheterInnovative Health, LLC2017-06-161200
K170311Reprocessed Agilis NxT Steerable IntroducerInnovative Health, LLC2017-06-021210
K162251Reprocessed Viking Diagnostic Electrophysiology CathetersInnovative Health, LLC2016-12-211330
K161827Reprocessed Response Diagnostic Electrophysiology CathetersInnovative Health, LLC2016-12-081560
K161769Reprocessed Supreme Diagnostic Electrophysiology CathetersInnovative Health, LLC2016-12-061610
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
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
K153090Reprocessed Diagnostic Ultrasound CatheterInnovative Health, LLC2016-03-101360

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