Cleared Traditional

Somnera System (K200698) - FDA 510(k) Clearance

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

K200698 · Fresca Medical, Inc. · Anesthesiology device
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Jun 2020
Decision
104d
Days
Class 2
Risk

K200698 is an FDA 510(k) clearance for the Somnera System. Classified as Positive Airway Pressure System (product code QBY), Class II - Special Controls.

Submitted by Fresca Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on June 29, 2020 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5273 - 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 Fresca Medical, Inc. devices

Submission Details

510(k) Number K200698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2020
Decision Date June 29, 2020
Days to Decision 104 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
35d faster than avg
Panel avg: 139d · This submission: 104d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QBY Positive Airway Pressure System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5273
Definition A Positive Airway Pressure Delivery System Is A Prescription Noninvasive Ventilatory Device That Delivers Expiratory Positive Airway Pressure For Patients Suffering From Obstructive Sleep Apnea. The System Also Provides Positive Airway Pressure During Incipient Apnea. The System May Include A Dedicated Flow Generator And A Patient Interface.
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.

Clinical Evidence

ClinicalTrials.gov
NCT03999944 Completed Interventional Industry-sponsored

Non-Inferiority Study of the FRESCA Airbox Positive Airway Pressure System

Non-Inferiority Study of the FRESCA Airbox Positive Airway Pressure System Versus the (Predicate) FRESCA Positive Airway Pressure System for the Treatment of Obstructive Sleep Apnea

52
Patients (actual)
6
Sites
Treatment
Purpose
Single blind
Masking
Condition studied Sleep Apnea
Study design Crossover
Eligibility All sexes · 22 Years+
Principal investigator Mark Goetting, MD
Sponsor FRESCA Medical (industry)
Started 2019-10-14 → Primary completion 2020-01-07
Primary outcome
Apnea-Hypopnea Index (AHI)
Secondary outcome
Oxygen Desaturation Index (ODI)
View full study on ClinicalTrials.gov