Cleared Traditional

K191170 - Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter

K191170 is an FDA 510(k) clearance for Reprocessed Reflexion Spiral Bi-Directi..., manufactured by Innovative Health, LLC. The device is a Class 2 Cardiovascular device with product code NLH cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K191170 · Innovative Health, LLC · Cardiovascular device
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Oct 2019
Decision
182d
Days
Class 2
Risk

K191170 is an FDA 510(k) clearance for the Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology.... Classified as Catheter, Recording, Electrode, Reprocessed (product code NLH), Class II - Special Controls.

Submitted by Innovative Health, LLC (Scottsdale, US). The FDA issued a Cleared decision on October 30, 2019 after a review of 182 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Innovative Health, LLC devices

FDA 510(k) Submission Details - K191170

510(k) Number K191170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2019
Decision Date October 30, 2019
Days to Decision 182 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 125d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NLH Device Classification - Class 2, Special Controls

Product Code NLH Catheter, Recording, Electrode, Reprocessed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1220
Definition Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - NLH Catheter, Recording, Electrode, Reprocessed

All 68
Devices cleared under the same product code (NLH) and FDA review panel - the closest regulatory comparables to K191170.
Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)
K203655 · Innovative Health, LLC · May 2021
Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled
K200205 · Stryker Sustainability Solutions · May 2020
Reprocessed Achieve Catheter Connecting Cable
K193263 · Innovative Health, LLC · Jan 2020
Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter
K190127 · Innovative Health, LLC · Aug 2019
Reprocessed Response Diagnostic Electrophysiology Catheter
K182488 · Innovative Health, LLC · Feb 2019
Reprocessed CS Diagnostic Electrophysiology Catheter
K181056 · Stryker Sustainability Solutions · Jan 2019