Cleared Traditional

K802943 - POSITIVE END EXPIRATORY PRESSURE VALVE

K802943 is the FDA 510(k) clearance for POSITIVE END EXPIRATORY PRESSURE VALVE by Fraser Harlake, Inc.. It is a Class 2 Anesthesiology device (product code BYE) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K802943 · Fraser Harlake, Inc. · Anesthesiology device
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Jan 1981
Decision
57d
Days
Class 2
Risk

K802943 is an FDA 510(k) clearance for the POSITIVE END EXPIRATORY PRESSURE VALVE. Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Fraser Harlake, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 15, 1981 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5965 - 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 Fraser Harlake, Inc. devices

Submission Details

510(k) Number K802943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1980
Decision Date January 15, 1981
Days to Decision 57 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 140d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BYE Attachment, Breathing, Positive End Expiratory Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5965
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 - BYE Attachment, Breathing, Positive End Expiratory Pressure

All 22
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K802943.
DOWNS ADJUSTABLE FLOW GENERATOR
K831503 · Vital Signs, Inc. · Sep 1983
PEEP SYSTEM D
K831301 · Draeger Medical, Inc. · Jun 1983
PEEP VALVE
K820404 · Vital Signs, Inc. · Mar 1982
DRAGER PEEP CONTROL SYSTEM
K802707 · Draeger Medical, Inc. · Nov 1980
VITAL SIGNS PEEP VALVE
K802070 · Vital Signs, Inc. · Sep 1980