Cleared Traditional

K920443 - MININEB

K920443 is an FDA 510(k) clearance for MININEB, manufactured by Vortran Medical Technology 1, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K920443 · Vortran Medical Technology 1, Inc. · Anesthesiology device
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Jul 1992
Decision
150d
Days
Class 2
Risk

K920443 is an FDA 510(k) clearance for the MININEB. 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 July 2, 1992 after a review of 150 days - an extended review 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: 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 Vortran Medical Technology 1, Inc. devices

FDA 510(k) Submission Details - K920443

510(k) Number K920443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1992
Decision Date July 02, 1992
Days to Decision 150 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 140d · This submission: 150d
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 K920443.
HEART NEBULIZER
K923596 · Vortran Medical Technology 1, Inc. · Oct 1992
NE-U07
K922923 · Omron Healthcare, Inc. · Sep 1992
NE-U04/NE U04F
K923024 · Omron Healthcare, Inc. · Sep 1992
HEART NUBULIZER
K920332 · Vortran Medical Technology 1, Inc. · May 1992
OMRON COMPRESSOR NEBULIZER- MODEL NE-C09
K914836 · Omron Healthcare, Inc. · May 1992
DP 100
K911192 · Ferguson Medical · Dec 1991