Cleared Traditional

K896696 - (HEART) NEBULIZER

K896696 is the FDA 510(k) clearance for (HEART) NEBULIZER by Vortran Medical Technology 1, Inc.. It is a Class 2 Anesthesiology device (product code CAF) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K896696 · Vortran Medical Technology 1, Inc. · Anesthesiology device
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Feb 1990
Decision
76d
Days
Class 2
Risk

K896696 is an FDA 510(k) clearance for the (HEART) NEBULIZER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Vortran Medical Technology 1, Inc. (Sacramento, US). The FDA issued a Cleared decision on February 12, 1990 after a review of 76 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 Vortran Medical Technology 1, Inc. devices

Submission Details

510(k) Number K896696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1989
Decision Date February 12, 1990
Days to Decision 76 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 140d · This submission: 76d
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 94
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K896696.
MISTY OX TURBOHEATER
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K883964 · Baxter Healthcare Corp · Nov 1988
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K851436 · Invacare Corp. · Jul 1985