Cleared Traditional

VEOLAR VENTILATOR (K871792) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K871792 · Hamilton Medical, Inc. · Anesthesiology device
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Apr 1988
Decision
350d
Days
Class 2
Risk

K871792 is an FDA 510(k) clearance for the VEOLAR VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Hamilton Medical, Inc. (Reno, US). The FDA issued a Cleared decision on April 21, 1988 after a review of 350 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Hamilton Medical, Inc. devices

Submission Details

510(k) Number K871792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1987
Decision Date April 21, 1988
Days to Decision 350 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
210d slower than avg
Panel avg: 140d · This submission: 350d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 110
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K871792.
ADVENT VENTILATOR
K884793 · Ohmeda Medical · Jun 1989
OHMEDA 7800 ANESTHESIA VENTILATOR
K883159 · Ohmeda Medical · Jun 1989
MODEL 7200A, PRESSURE VENTILATION OPTION
K873151 · Puritan Bennett Corp. · May 1988
CPU 1100 VENTILATOR
K880054 · Ohmeda Medical · Apr 1988
COMPANION 2800A PORTABLE VENTILATOR - MODIFICATION
K873215 · Puritan Bennett Corp. · Jan 1988
CPU-1 INTENSIVE CARE VENTILATOR
K871398 · Ohmeda Medical · May 1987