Cleared Traditional

K790892 - MISTY NEBULIZER

K790892 is the FDA 510(k) clearance for MISTY NEBULIZER by Airlife, Inc.. It is a Class 2 Anesthesiology device (product code CAF) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K790892 · Airlife, Inc. · Anesthesiology device
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Jul 1979
Decision
78d
Days
Class 2
Risk

K790892 is an FDA 510(k) clearance for the MISTY NEBULIZER. 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 July 24, 1979 after a review of 78 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

Submission Details

510(k) Number K790892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1979
Decision Date July 24, 1979
Days to Decision 78 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
62d faster than avg
Panel avg: 140d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 93
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K790892.
UNIVERSAL TWO-PIECE MACHINES
K791444 · Airlife, Inc. · Aug 1979
TWO-PIECE IPPB MANIFOLD MACHINES
K791445 · Airlife, Inc. · Aug 1979
INHALATION OPERATED NEBULIZER CODE
K791218 · Travenol Laboratories, S.A. · Jul 1979
SHERWOOD NEBULIZER KIT
K791089 · Sherwood Medical Co. · Jul 1979
INSPIRON NEBULO TM 28 NEBULIZER KIT
K790982 · C.R. Bard, Inc. · Jun 1979
I.P.P.B. MANIFOLD & NEBULIZER, UNIVERSAL
K791042 · Airlife, Inc. · Jun 1979