Cleared Traditional

K853501 - HONEYWELL ELECTRONIC VENTILATOR EV-A

K853501 is an FDA 510(k) clearance for HONEYWELL ELECTRONIC VENTILATOR EV-A, manufactured by Honeywell, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K853501 · Honeywell, Inc. · Anesthesiology device
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Apr 1986
Decision
227d
Days
Class 2
Risk

K853501 is an FDA 510(k) clearance for the HONEYWELL ELECTRONIC VENTILATOR EV-A. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Honeywell, Inc. (Pleasantville, US). The FDA issued a Cleared decision on April 4, 1986 after a review of 227 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 Honeywell, Inc. devices

FDA 510(k) Submission Details - K853501

510(k) Number K853501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1985
Decision Date April 04, 1986
Days to Decision 227 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
87d slower than avg
Panel avg: 140d · This submission: 227d
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 239
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K853501.
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
MODIFICATION 7200 MICROPROCESSOR VENTILATOR SYSTEM
K854070 · Puritan Bennett Corp. · Feb 1986
7200 MICROPROCESSOR VENTILATOR SYSTEM RESPIRATORY
K854300 · Puritan Bennett Corp. · Jan 1986
ADULT VENTILATOR TESTER VT-1
K853760 · Bio-Tek Instruments, Inc. · Dec 1985