Cleared Traditional

K820746 - NEWPORT VENTILATOR MODEL E100

K820746 is an FDA 510(k) clearance for NEWPORT VENTILATOR MODEL E100, 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 28-day FDA review.

K820746 · Newport Medical Instruments, Inc. · Anesthesiology device
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Apr 1982
Decision
28d
Days
Class 2
Risk

K820746 is an FDA 510(k) clearance for the NEWPORT VENTILATOR MODEL E100. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Newport Medical Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 16, 1982 after a review of 28 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Newport Medical Instruments, Inc. devices

FDA 510(k) Submission Details - K820746

510(k) Number K820746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1982
Decision Date April 16, 1982
Days to Decision 28 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 140d · This submission: 28d
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 K820746.
ABT 4000 VENTILATOR
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SECHRIST MODEL 990 JET VENTILATOR
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OHIO 7000 ELECTRONIC ANESTHESIA VENTIL.
K821376 · Ohio Medical Products · Jun 1982
ANESTHESIA VENTILATOR
K820393 · Puritan Bennett Corp. · Mar 1982
JET VENTILATOR
K813254 · Healthdyne, Inc. · Feb 1982
BABYBIRD 2 VENTILATOR
K820132 · 3M Company · Jan 1982