Cleared Traditional

RELIEVA ULTIRRA Sinus Balloon Catheter (K190525) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K190525 · Acclarent, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
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May 2019
Decision
60d
Days
Class 1
Risk

K190525 is an FDA 510(k) clearance for the RELIEVA ULTIRRA Sinus Balloon Catheter. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by Acclarent, Inc. (Irvin, US). The FDA issued a Cleared decision on May 3, 2019 after a review of 60 days - a notably fast clearance cycle.

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: 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 Acclarent, Inc. devices

Submission Details

510(k) Number K190525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2019
Decision Date May 03, 2019
Days to Decision 60 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
29d faster than avg
Panel avg: 89d · This submission: 60d
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 64
Devices cleared under the same product code (LRC) and FDA review panel - the closest regulatory comparables to K190525.
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VenSure Balloon Device, VenSure Nav Balloon Device
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Dillard Nasal Balloon Catheter
K181546 · Intuit Medical Products, LLC · Jan 2020