Cleared Traditional

K111146 - NEWPORT HT70 VENTILATOR (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K111146 · Newport Medical Instruments, Inc. · Anesthesiology device
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Dec 2011
Decision
223d
Days
Class 2
Risk

K111146 is an FDA 510(k) clearance for the NEWPORT HT70 VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Newport Medical Instruments, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on December 1, 2011 after a review of 223 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 Newport Medical Instruments, Inc. devices

Submission Details

510(k) Number K111146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2011
Decision Date December 01, 2011
Days to Decision 223 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 139d · This submission: 223d
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 503
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