Cleared Traditional

Juno VPAP ST-A (K161492) - FDA 510(k) Clearance

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

K161492 · Resmed, Ltd. · Anesthesiology device
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Jan 2017
Decision
232d
Days
Class 2
Risk

K161492 is an FDA 510(k) clearance for the Juno VPAP ST-A. Classified as Ventilator, Continuous, Non-life-supporting (product code MNS), Class II - Special Controls.

Submitted by Resmed, Ltd. (Bella Vista Nsw 2153, AU). The FDA issued a Cleared decision on January 19, 2017 after a review of 232 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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 Resmed, Ltd. devices

Submission Details

510(k) Number K161492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2016
Decision Date January 19, 2017
Days to Decision 232 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
93d slower than avg
Panel avg: 139d · This submission: 232d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MNS Ventilator, Continuous, Non-life-supporting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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

Resmed Corp
Larissa D'Andrea

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
NCT02317042 Terminated Interventional Industry-sponsored

Juno Perth Clinical Trial

The Evaluation of the Sleep-Breathing Treatment Algorithm: AutoEPAP iVAPS

25
Patients (actual)
2
Sites
Treatment
Purpose
Triple
Masking
Condition studied Respiratory Insufficiency; Obesity Hypoventilation Syndrome; Chronic Obstructive Pulmonary Disease (COPD); Neuromuscular Disease; Upper Airway Obstruction
Study design Crossover
Eligibility All sexes · 18 Years+
Sponsor ResMed (industry)
Started 2015-05-29 → Primary completion 2015-11-01 → Completed 2015-11-29
Primary outcome
Apnoea-Hypopnoea Index (AHI)
Secondary outcome
Oxygen Desaturation Index
View full study on ClinicalTrials.gov

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