Cleared Traditional

K160836 - Menai System

K160836 is an FDA 510(k) clearance for Menai System, manufactured by Resmed, Ltd.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K160836 · Resmed, Ltd. · Anesthesiology device
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Dec 2016
Decision
265d
Days
Class 2
Risk

K160836 is an FDA 510(k) clearance for the Menai System. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Resmed, Ltd. (Bella Vista, AU). The FDA issued a Cleared decision on December 15, 2016 after a review of 265 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.

View all Resmed, Ltd. devices

FDA 510(k) Submission Details - K160836

510(k) Number K160836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2016
Decision Date December 15, 2016
Days to Decision 265 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
125d slower than avg
Panel avg: 140d · This submission: 265d
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

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
NCT02255539 Completed Interventional Industry-sponsored

Bioburden and Usability Evaluation of a Nasal Prototype CPAP Mask

Bioburden and Usability Study of the Geelong Mask System

42
Patients (actual)
1
Site
Supportive_care
Purpose
Open label
Masking
Condition studied Obstructive Sleep Apnea
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Klaus Schindhelm, BE PhD
Sponsor ResMed (industry)
Started 2015-01-01 → Primary completion 2015-03-01
Primary outcome
Changes from baseline in Bioburden and Impedance of the prototype mask components at 6 weeks
Secondary outcome
Usability ratings of the prototype mask using a visual analog scale, compared to a reference level and the participant's current mask
Study completed - no results published. This trial concluded in 2015 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 391
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K160836.
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K161412 · Fisher &Paykel Healthcare , Ltd. · Jan 2017
AirFit N20
K161978 · Resmed, Ltd. · Nov 2016
iCodeConnect
K160127 · 3B Medical, Inc. · Nov 2016
F&P Eson 2 Nasal Mask
K153505 · Fisher & Paykel Healthcare Limited · Sep 2016