Cleared Traditional

K871433 - PPG BIOMEDICAL VENTILATOR MODEL AV 400

K871433 is the FDA 510(k) clearance for PPG BIOMEDICAL VENTILATOR MODEL AV 400 by Ppg Industries, Inc.. It is a Class 2 Anesthesiology device (product code CBK) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K871433 · Ppg Industries, Inc. · Anesthesiology device
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May 1987
Decision
46d
Days
Class 2
Risk

K871433 is an FDA 510(k) clearance for the PPG BIOMEDICAL VENTILATOR MODEL AV 400. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Ppg Industries, Inc. (Pleasantville, US). The FDA issued a Cleared decision on May 29, 1987 after a review of 46 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 Ppg Industries, Inc. devices

Submission Details

510(k) Number K871433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1987
Decision Date May 29, 1987
Days to Decision 46 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 140d · This submission: 46d
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 122
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K871433.
PRESSURE LIMIT CONTROL
K874415 · Draeger Medical, Inc. · Jan 1988
ASCENDING VENTILATOR BELLOWS
K874371 · Draeger Medical, Inc. · Dec 1987
PEDIATRIC BELLOWS
K873549 · Draeger Medical, Inc. · Oct 1987
CPU-1 INTENSIVE CARE VENTILATOR
K871398 · Ohmeda Medical · May 1987
COMPANION 2800 PORTABLE VOLUME VENTILATOR
K870275 · Puritan Bennett Corp. · Mar 1987
PEDIATRIC BELLOWS
K864431 · Draeger Medical, Inc. · Jan 1987