Cleared Traditional

K133868 - ASTRAL VENTILATOR

K133868 is the FDA 510(k) clearance for ASTRAL VENTILATOR by Resmed, Ltd.. It is a Class 2 Anesthesiology device (product code CBK) cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K133868 · Resmed, Ltd. · Anesthesiology device
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Jun 2014
Decision
166d
Days
Class 2
Risk

K133868 is an FDA 510(k) clearance for the ASTRAL VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Resmed, Ltd. (San Diego, US). The FDA issued a Cleared decision on June 4, 2014 after a review of 166 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 K133868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2013
Decision Date June 04, 2014
Days to Decision 166 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
26d slower than avg
Panel avg: 140d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBK Ventilator, Continuous, Facility Use
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 - CBK Ventilator, Continuous, Facility Use

All 193
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K133868.
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