Cleared Traditional

K790887 - TEE ADAPTER

K790887 is the FDA 510(k) clearance for TEE ADAPTER by Airlife, Inc.. It is a Class 1 Anesthesiology device (product code BZA) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K790887 · Airlife, Inc. · Anesthesiology device
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Jun 1979
Decision
29d
Days
Class 1
Risk

K790887 is an FDA 510(k) clearance for the TEE ADAPTER. Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 5, 1979 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5810 - 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 K790887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1979
Decision Date June 05, 1979
Days to Decision 29 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
111d faster than avg
Panel avg: 140d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BZA Connector, Airway (extension)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5810
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 - BZA Connector, Airway (extension)

All 17
Devices cleared under the same product code (BZA) and FDA review panel - the closest regulatory comparables to K790887.
UNIVERSAL ADAPTER SYSTEM-U/ADAPIT
K811708 · Airlife, Inc. · Jul 1981
BLOW-BY-SET-UP CONNECTOR-AIRWAY
K802663 · Airlife, Inc. · Nov 1980
TRACH T WITH ONE-WAY VALVES
K790888 · Airlife, Inc. · Jun 1979
TRACH T W/DRAINAGE BAG
K790156 · Airlife, Inc. · Apr 1979
CUFF CONNECTOR
K790148 · Airlife, Inc. · Feb 1979
MASK INTULATION ADAPTOR
K790149 · Airlife, Inc. · Feb 1979