Cleared Traditional

RELIEVA SINUS BALLOON DILATION CATHETER (K043527) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K043527 · Exploramed Nc1, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
105d
Days
Class 1
Risk

K043527 is an FDA 510(k) clearance for the RELIEVA SINUS BALLOON DILATION CATHETER. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by Exploramed Nc1, Inc. (Mountain View, US). The FDA issued a Cleared decision on April 5, 2005 after a review of 105 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 Exploramed Nc1, Inc. devices

Submission Details

510(k) Number K043527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2004
Decision Date April 05, 2005
Days to Decision 105 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
16d slower than avg
Panel avg: 89d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 11
Devices cleared under the same product code (LRC) and FDA review panel - the closest regulatory comparables to K043527.
Dillard Nasal Balloon Catheter
K181546 · Intuit Medical Products, LLC · Jan 2020
RELIEVA ULTIRRA Sinus Balloon Catheter
K190525 · Acclarent, Inc. · May 2019
Sinusway Dilation System
K181838 · 3nt Medical , Ltd. · Dec 2018
DISPOSABLE NASAL SCISSOR
K942063 · United States Surgical, A Division of Tyco Healthc · Jun 1994
DISPOSABLE NASAL RONGEUR
K942064 · United States Surgical, A Division of Tyco Healthc · Jun 1994
DISPOSABLE ENT PUNCH
K942065 · United States Surgical, A Division of Tyco Healthc · Jun 1994