Cleared Traditional

K834077 - SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN

K834077 is an FDA 510(k) clearance for SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN, manufactured by Airlife, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K834077 · Airlife, Inc. · Anesthesiology device
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Dec 1983
Decision
17d
Days
Class 2
Risk

K834077 is an FDA 510(k) clearance for the SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 12, 1983 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - 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

FDA 510(k) Submission Details - K834077

510(k) Number K834077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1983
Decision Date December 12, 1983
Days to Decision 17 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
123d faster than avg
Panel avg: 140d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAF Device Classification - Class 2, Special Controls

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
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 - CAF Nebulizer (direct Patient Interface)

All 229
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K834077.
SERVO NEBULIZER 945 SIEMENS-ELEMA AB
K871293 · Siemens Elema AB · May 1987
NEBULAIRE (IRC 1040) NEBULIZER PUMP
K851436 · Invacare Corp. · Jul 1985
VARIABLE NEBULIZER HEATER
K851074 · Travenol Laboratories, S.A. · Jun 1985
NEBULIZER ACCESSORY FOR SERVO VENTILL
K832898 · Siemens Elema AB · Nov 1983
DISPOS. MEDICATION NEBULIZER
K831270 · Hospitak, Inc. · Jun 1983
SINGLE USE NEBULIZER, ADJUST. AIR-
K830895 · Airlife, Inc. · Apr 1983