Cleared Traditional

K883593 - #400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAY (FDA 510(k) Clearance)

Class I Anesthesiology device.

K883593 · Ecolab, Inc. · Anesthesiology device
Sep 1988
Decision
38d
Days
Class 1
Risk

K883593 is an FDA 510(k) clearance for the #400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAY. Classified as Airway, Oropharyngeal, Anesthesiology (product code CAE), Class I - General Controls.

Submitted by Ecolab, Inc. (St. Paul, US). The FDA issued a Cleared decision on September 30, 1988 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5110 - 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.

Submission Details

510(k) Number K883593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1988
Decision Date September 30, 1988
Days to Decision 38 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Regulatory Context
Review time vs. panel average
187d faster than avg
Panel avg: 225d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAE Airway, Oropharyngeal, Anesthesiology
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5110
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.