Cleared Traditional

K161827 - Reprocessed Response Diagnostic Electro...

K161827 is the FDA 510(k) clearance for Reprocessed Response Diagnostic Electro... by Innovative Health, LLC. It is a Class 2 Cardiovascular device (product code NLH) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K161827 · Innovative Health, LLC · Cardiovascular device
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Dec 2016
Decision
156d
Days
Class 2
Risk

K161827 is an FDA 510(k) clearance for the Reprocessed Response Diagnostic Electrophysiology Catheters. 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 December 8, 2016 after a review of 156 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

Submission Details

510(k) Number K161827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2016
Decision Date December 08, 2016
Days to Decision 156 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
31d slower than avg
Panel avg: 125d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 51
Devices cleared under the same product code (NLH) and FDA review panel - the closest regulatory comparables to K161827.
Reprocessed CristaCath Diagnostic Electrophysiology Catheter
K171503 · Innovative Health, LLC · Oct 2017
Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)
K170922 · Innovative Health, LLC · Jun 2017
Reprocessed Viking Diagnostic Electrophysiology Catheters
K162251 · Innovative Health, LLC · Dec 2016
Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter
K160421 · Innovative Health, LLC · Nov 2016
Reprocessed Orbiter ST Steerable Diagnostic EP Catheter
K161393 · Innovative Health, LLC · Oct 2016
Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters
K161464 · Innovative Health, LLC · Sep 2016