Cleared Traditional

K943600 - UNIHEART

K943600 is the FDA 510(k) clearance for UNIHEART 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 80-day FDA review.

K943600 · Vortran Medical Technology 1, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
80d
Days
Class 2
Risk

K943600 is an FDA 510(k) clearance for the UNIHEART. 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 October 13, 1994 after a review of 80 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 K943600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1994
Decision Date October 13, 1994
Days to Decision 80 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 140d · This submission: 80d
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 K943600.
MODEL IRC 1199 SCOUT NEBULIZER
K973468 · Invacare Corp. · Dec 1997
MISTY OX TURBOHEATER
K962438 · Vital Signs, Inc. · Jan 1997
BAXTER NEBULIZER CAP MODEL 2D0868
K962161 · Baxter Healthcare Corp · Aug 1996
COMPANION 800 PORTABLE NEBULIZER COMPRESSOR (C800)
K921809 · Puritan Bennett Corp. · Dec 1992
OMRON ULTRASONIC NEBULIZER NE-U06
K875134 · Nidek, Inc. · Dec 1988
AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER
K883964 · Baxter Healthcare Corp · Nov 1988