Cleared Traditional

K152121 - NuVent EM Sinus Dilation System

K152121 is an FDA 510(k) clearance for NuVent EM Sinus Dilation System, manufactured by Medtronic Xomed, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code LRC cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K152121 · Medtronic Xomed, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
124d
Days
Class 1
Risk

K152121 is an FDA 510(k) clearance for the NuVent EM Sinus Dilation System. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on December 1, 2015 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - the FDA ear, nose and throat device 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Xomed, Inc. devices

FDA 510(k) Submission Details - K152121

510(k) Number K152121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2015
Decision Date December 01, 2015
Days to Decision 124 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 90d · This submission: 124d
Pathway characteristics
Predicate-based equivalence.

LRC Device Classification - Class 1, General Controls

Product Code LRC Instrument, Ent Manual Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LRC Instrument, Ent Manual Surgical

All 62
Devices cleared under the same product code (LRC) and FDA review panel - the closest regulatory comparables to K152121.
Relieva UltirraNav Sinus Balloon Catheter
K161698 · Acclarent, Inc. · Oct 2016
Vent-Os Sinus Dilation family
K160770 · Sinusys Corporation · Jun 2016
Relieva Scout Multi-Sinus Dilation System
K153341 · Acclarent, Inc. · Feb 2016
XprESS Multi-Sinus Dilation System
K152434 · Entellus Medical, Inc. · Nov 2015
PassAssist LED Light Fiber
K152435 · Entellus Medical, Inc. · Nov 2015
DSS Sinusplasty Balloon Catheter
K143738 · Intuit Medical Products, LLC · Aug 2015