Cleared Traditional

K170922 - Reprocessed Webster CS Bi-Directional D...

K170922 is the FDA 510(k) clearance for Reprocessed Webster CS Bi-Directional D... by Innovative Health, LLC. It is a Class 2 Cardiovascular device (product code NLH) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K170922 · Innovative Health, LLC · Cardiovascular device
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Jun 2017
Decision
85d
Days
Class 2
Risk

K170922 is an FDA 510(k) clearance for the Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Web.... 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 June 22, 2017 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Innovative Health, LLC devices

Submission Details

510(k) Number K170922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2017
Decision Date June 22, 2017
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
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 K170922.
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