Cleared Traditional

K964078 - 3050 SPORT-NEB

K964078 is an FDA 510(k) clearance for 3050 SPORT-NEB, manufactured by Medical Industries America, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K964078 · Medical Industries America, Inc. · Anesthesiology device
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Jan 1997
Decision
91d
Days
Class 2
Risk

K964078 is an FDA 510(k) clearance for the 3050 SPORT-NEB. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Medical Industries America, Inc. (Adel, US). The FDA issued a Cleared decision on January 10, 1997 after a review of 91 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Industries America, Inc. devices

FDA 510(k) Submission Details - K964078

510(k) Number K964078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1996
Decision Date January 10, 1997
Days to Decision 91 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 140d · This submission: 91d
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 219
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K964078.
MODEL IRC 1199 SCOUT NEBULIZER
K973468 · Invacare Corp. · Dec 1997
COMPRESSOR/NEBULIZER #3650
K970289 · Devilbiss Health Care, Inc. · Apr 1997
MISTY OX TURBOHEATER
K962438 · Vital Signs, Inc. · Jan 1997
HEART NEBULIZER #100609
K963910 · Vortran Medical Technology 1, Inc. · Dec 1996
SALTERLABS 8660 SERIES NEBULIZER
K962879 · Salter Labs · Oct 1996
SALTER LABS 8990 SERIES NEBULIZER
K962085 · Salter Labs · Aug 1996