Cleared Traditional

K161827 - Reprocessed Response Diagnostic Electrophysiology Catheters

K161827 is an FDA 510(k) clearance for Reprocessed Response Diagnostic Electro..., 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 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

FDA 510(k) Submission Details - K161827

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.

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 K161827.
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
Supreme and Response Electrophysiology Catheters
K161272 · Surgical Instrument Service and Savings, Inc. · May 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