Cleared Traditional

K111254 - RELIEVA SOLO ELITE SINUS BALLOON CATHETER

K111254 is an FDA 510(k) clearance for RELIEVA SOLO ELITE SINUS BALLOON CATHETER, manufactured by Acclarent, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code LRC cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K111254 · Acclarent, Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Aug 2011
Decision
110d
Days
Class 1
Risk

K111254 is an FDA 510(k) clearance for the RELIEVA SOLO ELITE SINUS BALLOON CATHETER. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by Acclarent, Inc. (Rmenlo Park, US). The FDA issued a Cleared decision on August 22, 2011 after a review of 110 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 Acclarent, Inc. devices

FDA 510(k) Submission Details - K111254

510(k) Number K111254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2011
Decision Date August 22, 2011
Days to Decision 110 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 90d · This submission: 110d
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 59
Devices cleared under the same product code (LRC) and FDA review panel - the closest regulatory comparables to K111254.
XPRESS MULTI-SINUS DILATION TOOL
K112506 · Entellus Medical, Inc. · Dec 2011
RELIEVA SPIN SINUS DILATION SYSTEM
K111875 · Acclarent, Inc. · Oct 2011
PATHASSIST LIGHT FIBER
K111763 · Entellus Medical, Inc. · Sep 2011
ENTELLUS MEDICAL SINUS GUIDEWIRE
K110739 · Entellus Medical, Inc. · Jun 2011
ILLUMINATING SINUS SEEKER
K110158 · Entellus Medical, Inc. · Jun 2011
XPRESS BALLOON DEVICE
K102003 · Entellus Medical, Inc. · Oct 2010