Cleared Traditional

K133016 - VENT-OS SINUS DILATION SYSTEM (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K133016 · Sinusys Corporation · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Dec 2013
Decision
75d
Days
Class 1
Risk

K133016 is an FDA 510(k) clearance for the VENT-OS SINUS DILATION SYSTEM. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by Sinusys Corporation (Orinda, US). The FDA issued a Cleared decision on December 9, 2013 after a review of 75 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 Sinusys Corporation devices

Submission Details

510(k) Number K133016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2013
Decision Date December 09, 2013
Days to Decision 75 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
14d faster than avg
Panel avg: 89d · This submission: 75d
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
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