Cleared Traditional

K043527 - RELIEVA SINUS BALLOON DILATION CATHETER

K043527 is an FDA 510(k) clearance for RELIEVA SINUS BALLOON DILATION CATHETER, manufactured by Exploramed Nc1, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code LRC cleared through the Traditional 510(k) pathway after a 105-day FDA review.

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

FDA 510(k) Submission Details - K043527

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.

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 55
Devices cleared under the same product code (LRC) and FDA review panel - the closest regulatory comparables to K043527.
ENTELLUS MEDICAL RS-SERIES SYSTEM
K072302 · Entellus Medical, Inc. · Apr 2008
RELIEVA SINUS BALLOON CATHETER
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K052198 · Acclarent, Inc. · Aug 2005
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K942746 · Exmoor Plastics , Ltd. · Aug 1994