Cleared Traditional

K120280 - RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM

K120280 is an FDA 510(k) clearance for RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM, 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 280-day FDA review.

K120280 · Acclarent, Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Nov 2012
Decision
280d
Days
Class 1
Risk

K120280 is an FDA 510(k) clearance for the RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by Acclarent, Inc. (Menlo Park, US). The FDA issued a Cleared decision on November 5, 2012 after a review of 280 days - an extended review 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: 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 - K120280

510(k) Number K120280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2012
Decision Date November 05, 2012
Days to Decision 280 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
190d slower than avg
Panel avg: 90d · This submission: 280d
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 K120280.
SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT
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K130503 · Entellus Medical, Inc. · Jun 2013
SINUS DILATION SYSTEM
K121351 · Entrigue Surgical, Inc. · Aug 2012
XPRESS MULTI-SINUS DILATION TOOL
K121943 · Entellus Medical, Inc. · Aug 2012
XPRESS MULTI-SINUS DILATION TOOL
K121174 · Entellus Medical, Inc. · May 2012