Cleared Traditional

K132606 - S9 CRONULLA FOR HER

K132606 is the FDA 510(k) clearance for S9 CRONULLA FOR HER by Resmed, Ltd.. It is a Class 2 Anesthesiology device (product code BZD) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K132606 · Resmed, Ltd. · Anesthesiology device
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Jan 2014
Decision
146d
Days
Class 2
Risk

K132606 is an FDA 510(k) clearance for the S9 CRONULLA FOR HER. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Resmed, Ltd. (San Diego, US). The FDA issued a Cleared decision on January 13, 2014 after a review of 146 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K132606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2013
Decision Date January 13, 2014
Days to Decision 146 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
6d slower than avg
Panel avg: 140d · This submission: 146d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.

Clinical Evidence

ClinicalTrials.gov
NCT01826513 Completed Interventional Industry-sponsored

AutoSet for Her Clinical Trial Protocol

25
Patients (actual)
1
Site
Treatment
Purpose
Single blind
Masking
Condition studied Obstructive Sleep Apnea
Study design Crossover
Eligibility Female only · 18 Years+
Principal investigator Peter Eastwood, MBBS FRACP
Sponsor ResMed (industry)
Started 2013-05-01 → Primary completion 2013-06-01
Primary outcome
Apnoea Hypopnoea Index (AHI)
Secondary outcome
Sleep Efficacy
View full study on ClinicalTrials.gov