Cleared Traditional

K052198 - RELIEVA SINUS BALLOON INFLATION DEVICE

K052198 is the FDA 510(k) clearance for RELIEVA SINUS BALLOON INFLATION DEVICE by Acclarent, Inc.. It is a Class 1 Ear, Nose, Throat device (product code LRC) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K052198 · Acclarent, Inc. · Ear, Nose, Throat device
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Aug 2005
Decision
19d
Days
Class 1
Risk

K052198 is an FDA 510(k) clearance for the RELIEVA SINUS BALLOON INFLATION DEVICE. 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 31, 2005 after a review of 19 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 K052198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2005
Decision Date August 31, 2005
Days to Decision 19 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
70d faster than avg
Panel avg: 89d · This submission: 19d
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 32
Devices cleared under the same product code (LRC) and FDA review panel - the closest regulatory comparables to K052198.
RELIEVA SPIN SINUS DILATION SYSTEM
K111875 · Acclarent, Inc. · Oct 2011
RELIEVA SOLO ELITE SINUS BALLOON CATHETER
K111254 · Acclarent, Inc. · Aug 2011
RELIEVA SINUS BALLOON CATHETER
K061903 · Acclarent, Inc. · Aug 2006
EXMOOR SUCTION CLEARANCE KIT
K990366 · Exmoor Plastics , Ltd. · Mar 1999
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K942745 · Exmoor Plastics , Ltd. · Sep 1994
SUCKER ENDS (ZOELLNER)
K942746 · Exmoor Plastics , Ltd. · Aug 1994