Cleared Traditional

K161487 - VPAP Adapt SV

K161487 is the FDA 510(k) clearance for VPAP Adapt SV by Resmed, Ltd.. It is a Class 2 Anesthesiology device (product code MNS) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K161487 · Resmed, Ltd. · Anesthesiology device
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Sep 2016
Decision
101d
Days
Class 2
Risk

K161487 is an FDA 510(k) clearance for the VPAP Adapt SV, VPAP Tx, S9 VPAP Tx. Classified as Ventilator, Continuous, Non-life-supporting (product code MNS), Class II - Special Controls.

Submitted by Resmed, Ltd. (Bella Vista, AU). The FDA issued a Cleared decision on September 9, 2016 after a review of 101 days - within the typical 510(k) review window.

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 K161487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2016
Decision Date September 09, 2016
Days to Decision 101 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
39d faster than avg
Panel avg: 140d · This submission: 101d
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
NCT00733343 Completed Interventional Industry-sponsored

Treatment of Predominant Central Sleep Apnoea by Adaptive Servo Ventilation in Patients With Heart Failure

Treatment of Sleep-Disordered Breathing With Predominant Central Sleep Apnea by Adaptive Servo Ventilation in Patients With Heart Failure

1325
Patients (actual)
127
Sites
Treatment
Purpose
Open label
Masking
Condition studied Heart Failure; Sleep Disordered Breathing
Study design Parallel
Eligibility All sexes · 22 Years+
Principal investigator Helmut Teschler, Prof.
Sponsor ResMed (industry)
Started 2008-02-01 → Primary completion 2015-04-01 → Completed 2015-06-01
Primary outcome
All Cause Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure
Secondary outcome
Death From Any Cause
View full study on ClinicalTrials.gov

Regulatory Peers - MNS Ventilator, Continuous, Non-life-supporting

All 35
Devices cleared under the same product code (MNS) and FDA review panel - the closest regulatory comparables to K161487.
BPAP System
K213169 · BMC Medical Co., Ltd. · Dec 2022
ReddyPort NIV Access Elbow
K171827 · Smd Manufacturing, LLC · Jan 2018
Juno VPAP ST-A
K161492 · Resmed, Ltd. · Jan 2017
Juno VPAP ST-A
K153061 · Resmed, Ltd. · Apr 2016
EASYCARE ONLINE
K132371 · Resmed, Ltd. · Nov 2013
S9 VPAP TX
K123511 · Resmed, Ltd. · Mar 2013