Cleared Traditional

K160101 - SinuBand (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K160101 · Bioinspire Technologies, Incorporated · Ear, Nose, Throat device
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Jul 2016
Decision
190d
Days
Class 1
Risk

K160101 is an FDA 510(k) clearance for the SinuBand. Classified as Splint, Intranasal Septal, Cber Led (product code QJL), Class I - General Controls.

Submitted by Bioinspire Technologies, Incorporated (Palo Alto, US). The FDA issued a Cleared decision on July 27, 2016 after a review of 190 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4780 - 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.

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Submission Details

510(k) Number K160101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2016
Decision Date July 27, 2016
Days to Decision 190 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
101d slower than avg
Panel avg: 89d · This submission: 190d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QJL Splint, Intranasal Septal, Cber Led
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4780
Definition Splint, Intranasal Septal, Cber Led
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.