Cleared Traditional

K791218 - INHALATION OPERATED NEBULIZER CODE

K791218 is the FDA 510(k) clearance for INHALATION OPERATED NEBULIZER CODE by Travenol Laboratories, S.A.. It is a Class 2 Anesthesiology device (product code CAF) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K791218 · Travenol Laboratories, S.A. · Anesthesiology device
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Jul 1979
Decision
28d
Days
Class 2
Risk

K791218 is an FDA 510(k) clearance for the INHALATION OPERATED NEBULIZER CODE. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Mchenry, US). The FDA issued a Cleared decision on July 30, 1979 after a review of 28 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 Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K791218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1979
Decision Date July 30, 1979
Days to Decision 28 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
112d faster than avg
Panel avg: 140d · This submission: 28d
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 134
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K791218.
TWO-PIECE IPPB MANIFOLD FOR SUPPLY LINE
K791443 · Airlife, Inc. · Aug 1979
UNIVERSAL TWO-PIECE MACHINES
K791444 · Airlife, Inc. · Aug 1979
TWO-PIECE IPPB MANIFOLD MACHINES
K791445 · Airlife, Inc. · Aug 1979
MISTY NEBULIZER
K790892 · Airlife, Inc. · Jul 1979
SHERWOOD NEBULIZER KIT
K791089 · Sherwood Medical Co. · Jul 1979
INSPIRON NEBULO TM 28 NEBULIZER KIT
K790982 · C.R. Bard, Inc. · Jun 1979