Cleared Traditional

K811890 - DISPOSABLE TRACH T OXYGENATOR

K811890 is the FDA 510(k) clearance for DISPOSABLE TRACH T OXYGENATOR by Airlife, Inc.. It is a Class 1 Anesthesiology device (product code BZA) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K811890 · Airlife, Inc. · Anesthesiology device

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Jul 1981

Decision

14d

Days

Class 1

Risk

K811890 is an FDA 510(k) clearance for the DISPOSABLE TRACH T OXYGENATOR. 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 July 15, 1981 after a review of 14 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	K811890 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 01, 1981
Decision Date	July 15, 1981
Days to Decision	14 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

126d faster than avg

Panel avg: 140d · This submission: 14d

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 K811890.

OHMEDA DOUBLE SWIVEL ADAPTER

K844656 · Ohmeda Medical · Feb 1985

INSPIRATORY FORCE PRESSURE ADAPTOR

K812067 · Airlife, Inc. · Aug 1981

PEDIATRIC DOUBLE SWIVEL CONNECTOR

K812000 · Mallinckrodt Critical Care · Aug 1981

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

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K811890

Airlife, Inc.

Mchenry, IL · US

Regulatory profile

76 submissions 76 cleared

100% clearance rate · Active in Anesthesiology

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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