Cleared Traditional

The iNAP One Sleep Therapy System (K193460) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence.

K193460 · Somnice, Inc. · Anesthesiology device
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May 2020
Decision
162d
Days
Class 2
Risk

K193460 is an FDA 510(k) clearance for the The iNAP One Sleep Therapy System. Classified as Intraoral Pressure Gradient Device (product code OZR), Class II - Special Controls.

Submitted by Somnice, Inc. (Hsinchu County, TW). The FDA issued a Cleared decision on May 26, 2020 after a review of 162 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 872.5570 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Somnice, Inc. devices

Submission Details

510(k) Number K193460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2019
Decision Date May 26, 2020
Days to Decision 162 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 139d · This submission: 162d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OZR Intraoral Pressure Gradient Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5570
Definition This Intraoral Device Is Electrically Powered And Operates By Reducing The Pressure In The Oral Cavity (by Way Of Tubing And A Noninvasive Oral Interface) To Create A Continuous Positive Pressure Gradient From The Airway To The Oral Cavity That Urges The Soft Palate And Tongue Forward. It Is Intended To Be Used While A Patient Is Sleeping To Treat 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 Anesthesiology devices follow this clearance model.

Regulatory Consultant

Maxis, LLC
Sujith Shetty

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
NCT02324790 Terminated Interventional Industry-sponsored

Pilot Study of Negative Pressure Sleep Therapy System to Treat Obstructive Sleep Apnea

A Multicenter Pilot Study on the Indications of Negative Pressure Sleep Therapy System for the Treatment of Obstructive Sleep Apnea (OSA)

34
Patients (actual)
4
Sites
Treatment
Purpose
Open label
Masking
Condition studied Obstructive Sleep Apnea
Study design Single group
Eligibility All sexes · 20 Years+
Principal investigator C.M. Lin, M.D.
Sponsor Somnics, Inc. (industry)
Started 2014-12-01 → Primary completion 2016-01-13
Primary outcome
Change from baseline of Apnea-Hypopnea Index (AHI)
Secondary outcome
Change from baseline of obstructive apnea reduction
View full study on ClinicalTrials.gov