Cleared Traditional

K943600 - UNIHEART

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

K943600 · Vortran Medical Technology 1, Inc. · Anesthesiology device
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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

FDA 510(k) Submission Details - K943600

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
Combination Product No
PCCP Authorized No
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.

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 K943600.
3002 AEROMAX
K942444 · Medical Industries America, Inc. · Mar 1995
4003 AEROLITE
K942208 · Medical Industries America, Inc. · Feb 1995
CAREPAK
K942350 · Precision Medical, Inc. · Dec 1994
AUTONEB ACCESSORY CROSS (AAC)
K944643 · Vortran Medical Technology 1, Inc. · Oct 1994
AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT
K935693 · Vortran Medical Technology 1, Inc. · Aug 1994
AEROCHAMBER W/MASK, MODIFIED
K930574 · Monaghan Medical Corp. · Jan 1994