Cleared Traditional

K844350 - NEWPORT VENTILATOR MODEL E-100

K844350 is an FDA 510(k) clearance for NEWPORT VENTILATOR MODEL E-100, 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 48-day FDA review.

K844350 · Newport Medical Instruments, Inc. · Anesthesiology device
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Dec 1984
Decision
48d
Days
Class 2
Risk

K844350 is an FDA 510(k) clearance for the NEWPORT VENTILATOR MODEL E-100. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Newport Medical Instruments, Inc. (Newport Beach, US). The FDA issued a Cleared decision on December 27, 1984 after a review of 48 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 - K844350

510(k) Number K844350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1984
Decision Date December 27, 1984
Days to Decision 48 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
92d faster than avg
Panel avg: 140d · This submission: 48d
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 K844350.
OHMEDA 7000 ELECTRONIC ANESTHESIA VENTILATOR
K851509 · Ohmeda Medical · Jul 1985
CONNECTION CABLE FOR SYNCHRONIZATION OF TWO SERVO
K850374 · Siemens Elema AB · Apr 1985
SERVO VENTILATOR 900D SIEMENS-ELEMA AB
K844912 · Siemens Elema AB · Dec 1984
POWER PACK 160 SIEMENS-ELEMA AB
K844590 · Siemens Elema AB · Nov 1984
MICROPROCESSOR 7200A VENTILATOR
K843424 · Puritan Bennett Corp. · Nov 1984
BEAR JET-150 VENTILATOR
K842688 · Bear Medical Systems, Inc. · Jul 1984