Cleared Traditional

K132371 - EASYCARE ONLINE

K132371 is the FDA 510(k) clearance for EASYCARE ONLINE by Resmed, Ltd.. It is a Class 2 Anesthesiology device (product code MNS) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K132371 · Resmed, Ltd. · Anesthesiology device
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Nov 2013
Decision
115d
Days
Class 2
Risk

K132371 is an FDA 510(k) clearance for the EASYCARE ONLINE. Classified as Ventilator, Continuous, Non-life-supporting (product code MNS), Class II - Special Controls.

Submitted by Resmed, Ltd. (San Diego, US). The FDA issued a Cleared decision on November 22, 2013 after a review of 115 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 K132371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2013
Decision Date November 22, 2013
Days to Decision 115 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
25d faster than avg
Panel avg: 140d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

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

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