Cleared Traditional

K181458 - Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter

K181458 is an FDA 510(k) clearance for Reprocessed Advisor FL Sensor Enabled C..., 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 145-day FDA review.

K181458 · Innovative Health, LLC · Cardiovascular device
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Oct 2018
Decision
145d
Days
Class 2
Risk

K181458 is an FDA 510(k) clearance for the Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter. 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 27, 2018 after a review of 145 days - within the typical 510(k) review window.

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 - K181458

510(k) Number K181458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2018
Decision Date October 27, 2018
Days to Decision 145 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
20d slower than avg
Panel avg: 125d · This submission: 145d
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 K181458.
Reprocessed Response Diagnostic Electrophysiology Catheter
K182488 · Innovative Health, LLC · Feb 2019
Reprocessed CS Diagnostic Electrophysiology Catheter
K181056 · Stryker Sustainability Solutions · Jan 2019
Reprocessed Marinr Diagnostic EP Catheter
K181897 · Innovative Health, LLC · Nov 2018
Reprocessed Torqr Diagnostic EP Catheter
K181618 · Innovative Health, LLC · Oct 2018
Reprocessed DecaNav Diagnostic Electrophysiology Catheter
K180710 · Innovative Health, LLC · Jun 2018
Reprocessed Halo XP Diagnostic Electrophysiology Catheter
K171788 · Innovative Health, LLC · Nov 2017