Cleared Traditional

Bongo (K180619) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence.

K180619 · Innomed Healthscience, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
160d
Days
Class 2
Risk

K180619 is an FDA 510(k) clearance for the Bongo. Classified as Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea (product code OHP), Class II - Special Controls.

Submitted by Innomed Healthscience, Inc. (Deerfield Beach, US). The FDA issued a Cleared decision on August 16, 2018 after a review of 160 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 872.5570 - 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 Innomed Healthscience, Inc. devices

Submission Details

510(k) Number K180619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2018
Decision Date August 16, 2018
Days to Decision 160 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
71d slower than avg
Panel avg: 89d · This submission: 160d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OHP Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5570
Definition Intranasal Device That Creates Expiratory Resistance For The Treatment Of Obstructive Sleep Apnea.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Consultant

Innomed Healthscience, Inc. C/O Promedic, LLC
Paul Dryden

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT02878590 Completed Interventional Industry-sponsored

Clinical Study for the BONGO Device in the Treatment of Obstructive Sleep Apnea (OSA)

Clinical Study for the BONGO Device in the Treatment of Obstructive Sleep Apnea

23
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Obstructive Sleep Apnea
Study design Single group
Eligibility All sexes · 21 Years+
Principal investigator jerrold kram, MD
Sponsor InnoMed Healthscience Inc. (industry)
Started 2016-09-01 → Primary completion 2017-11-30
Primary outcome
Change in Apnea-Hypopnea Index (AHI)
View full study on ClinicalTrials.gov