Cleared Traditional

K883809 - NEWPORT VENTILATOR MODEL E150

K883809 is an FDA 510(k) clearance for NEWPORT VENTILATOR MODEL E150, 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 288-day FDA review.

K883809 · Newport Medical Instruments, Inc. · Anesthesiology device
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Jun 1989
Decision
288d
Days
Class 2
Risk

K883809 is an FDA 510(k) clearance for the NEWPORT VENTILATOR MODEL E150. 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 June 23, 1989 after a review of 288 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 - K883809

510(k) Number K883809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1988
Decision Date June 23, 1989
Days to Decision 288 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
148d slower than avg
Panel avg: 140d · This submission: 288d
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 K883809.
8400ST VOLUME VENTILATOR
K894322 · Bird Products Corp. · Jan 1990
MODIFIED PERMCATH TRAY (2ND SUBMISSION)
K895779 · Quinton, Inc. · Dec 1989
PURITAN-BENNETT 7200SPI MICROPROCESSOR VENTILATOR
K893043 · Puritan Bennett Corp. · Aug 1989
ADVENT VENTILATOR
K884793 · Ohmeda Medical · Jun 1989
OHMEDA 7800 ANESTHESIA VENTILATOR
K883159 · Ohmeda Medical · Jun 1989
BEAR EVC-100 CONTROLLER
K882764 · Bear Medical Systems, Inc. · Sep 1988