Cleared Traditional

K810947 - AIR ENTRAINMENT TRACH T

K810947 is the FDA 510(k) clearance for AIR ENTRAINMENT TRACH T by Airlife, Inc.. It is a Class 1 Anesthesiology device (product code BYF) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K810947 · Airlife, Inc. · Anesthesiology device
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Jun 1981
Decision
56d
Days
Class 1
Risk

K810947 is an FDA 510(k) clearance for the AIR ENTRAINMENT TRACH T. Classified as Mask, Oxygen, Low Concentration, Venturi (product code BYF), Class I - General Controls.

Submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1981 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5600 - 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 Airlife, Inc. devices

Submission Details

510(k) Number K810947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1981
Decision Date June 02, 1981
Days to Decision 56 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
84d faster than avg
Panel avg: 140d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BYF Mask, Oxygen, Low Concentration, Venturi
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5600
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.

Regulatory Peers - BYF Mask, Oxygen, Low Concentration, Venturi

Devices cleared under the same product code (BYF) and FDA review panel - the closest regulatory comparables to K810947.
DUAL DIAL VENTURI STYLE MASK
K832725 · Airlife, Inc. · Sep 1983
PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN
K812066 · Airlife, Inc. · Aug 1981
ADULT & PEDIATRIC TRACHEOSTOMY MASKS
K810946 · Airlife, Inc. · Jun 1981
MASK, PERCENTO
K790146 · Airlife, Inc. · Feb 1979
2 JET SET
K771385 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1977