Cleared Traditional

K860438 - NEWPORT VENTILATOR MODEL E-100

K860438 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 91-day FDA review.

K860438 · Newport Medical Instruments, Inc. · Anesthesiology device
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May 1986
Decision
91d
Days
Class 2
Risk

K860438 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 May 6, 1986 after a review of 91 days - within the typical 510(k) review window.

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 - K860438

510(k) Number K860438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1986
Decision Date May 06, 1986
Days to Decision 91 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
49d faster than avg
Panel avg: 140d · This submission: 91d
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 K860438.
7200 MICROPROCESS VENT SYS/MODEL 7202 DISPLAY OPT
K862604 · Puritan Bennett Corp. · Aug 1986
MASTER PROGRAM FLOW & PRESSURE CO2 & LUNG MONITOR
K861707 · Siemens Elema AB · Jun 1986
ENGSTROM ERICA II RESPIRATOR
K862025 · Gambro, Inc. · Jun 1986
COMPANION 2800 VOLUME VENTILATOR REMOTE ALARM
K861488 · Puritan Bennett Corp. · May 1986
COMPANION 2800 VOLUME VENTILATOR REMOT ALARM
K860675 · Puritan Bennett Corp. · Apr 1986
HONEYWELL ELECTRONIC VENTILATOR EV-A
K853501 · Honeywell, Inc. · Apr 1986