Cleared Traditional

K172875 - Astral 100/150

K172875 is the FDA 510(k) clearance for Astral 100/150 by Resmed, Ltd.. It is a Class 2 Anesthesiology device (product code CBK) cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K172875 · Resmed, Ltd. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Apr 2018
Decision
217d
Days
Class 2
Risk

K172875 is an FDA 510(k) clearance for the Astral 100/150. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Resmed, Ltd. (Bella Vista, AU). The FDA issued a Cleared decision on April 26, 2018 after a review of 217 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 K172875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2017
Decision Date April 26, 2018
Days to Decision 217 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
77d slower than avg
Panel avg: 140d · This submission: 217d
Pathway characteristics
Predicate-based equivalence.

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. 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 (Registration Number: 3007573469)
Sheila Bruschi

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
NCT02683772 Completed Interventional Industry-sponsored

Astral VAPS AutoEPAP Clinical Trial

The Evaluation of the Astral VAPS AutoEPAP Treatment Algorithm

42
Patients (actual)
5
Sites
Treatment
Purpose
Single blind
Masking
Condition studied Upper Airway Obstruction; Respiratory Insufficiency; Respiratory Failure
Study design Crossover
Eligibility All sexes · 18 Years+
Principal investigator Lisa Wolfe, MD
Sponsor ResMed (industry)
Started 2016-04-15 → Primary completion 2017-03-01 → Completed 2017-07-06
Primary outcome
Oxygen Desaturation Index 4% (ODI4%)
Secondary outcome
Sleep Efficiency (%)
View full study on ClinicalTrials.gov

Regulatory Peers - CBK Ventilator, Continuous, Facility Use

All 190
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K172875.
Savina 300
K180779 · Dragerwerk AG & CO Kgaa · Jan 2019
Nihon Kohden NKV-550 Series Ventilator System
K181695 · Nihon Kohden Orangemed, Inc. · Dec 2018
TV-100
K173973 · Bio-Med Devices, Inc. · Jul 2018
F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version
K173060 · Fisher and Paykel Healthcare Limited · Jan 2018
Puritan Bennett 980 Ventilator System
K162738 · Covidien · Oct 2017
Astral 100/150
K152068 · Resmed, Ltd. · May 2016