Cleared Traditional

K111146 - NEWPORT HT70 VENTILATOR

K111146 is an FDA 510(k) clearance for NEWPORT HT70 VENTILATOR, manufactured by Newport Medical Instruments, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 223-day FDA review.

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

FDA 510(k) Submission Details - K111146

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 140d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

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 274
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K111146.
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HAMILTON-TC1
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TRILOGY SERIES VENTILATOR WITH OXIMETRY
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