Cleared Traditional

K150365 - Cloud9 System

K150365 is an FDA 510(k) clearance for Cloud9 System, manufactured by Insleep Technologies, LLC. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K150365 · Insleep Technologies, LLC · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
159d
Days
Class 2
Risk

K150365 is an FDA 510(k) clearance for the Cloud9 System. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Insleep Technologies, LLC (Eden Prairie, US). The FDA issued a Cleared decision on July 21, 2015 after a review of 159 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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.

FDA 510(k) Submission Details - K150365

510(k) Number K150365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2015
Decision Date July 21, 2015
Days to Decision 159 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
19d slower than avg
Panel avg: 140d · This submission: 159d
Pathway characteristics
Predicate-based equivalence.

BZD Device Classification - Class 2, Special Controls

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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

Emergo Group
Adrienne Lenz

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
NCT01949584 Completed Interventional Industry-sponsored

Study of Nasal Airflow Pressure Optimization to Resolve Excessive Snoring

26
Patients (actual)
3
Sites
Treatment
Purpose
Open label
Masking
Condition studied Snoring
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Michael Lauk
Sponsor inSleep Technologies, LLC (industry)
Started 2013-08-01 → Primary completion 2014-07-01 → Completed 2014-12-01
Primary outcome
Efficacy - The Cloud9™ device is expected to reduce the incidence of snoring.
Secondary outcome
Safety - Adverse events associated with CPAP (nasal or skin irritation, epistaxis and sleep disruption) will occur in few subjects.
Study completed - no results published. This trial concluded in 2014 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - BZD Ventilator, Non-continuous (respirator)

All 458
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K150365.
Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series
K150111 · Apex Medical Corp. · Sep 2015
Skynector CPAP Mask
K150685 · Sky Wise Medical Instrument (Shen Zhen) Co., Ltd. · Aug 2015
CPAP Cannulaide
K143700 · Salter Labs · Aug 2015
Darlinghurst Vented, Darlinghurst NV-AAV
K143603 · Resmed, Ltd. · May 2015
LUNA CPAP AND AUTO-CPAP SYSTEM
K141770 · 3B Medical, Inc. · Apr 2015
TI NASAL MASK
K140980 · Respironics, Inc. · Feb 2015
K150365 · Cloud9 System
Download PDF FDA Summary Insleep Technologies,…