Cleared Traditional

K924649 - SOFT-MIST(TM)

K924649 is an FDA 510(k) clearance for SOFT-MIST(TM), 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 244-day FDA review.

K924649 · Vortran Medical Technology 1, Inc. · Anesthesiology device
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May 1993
Decision
244d
Days
Class 2
Risk

K924649 is an FDA 510(k) clearance for the SOFT-MIST(TM). 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 May 17, 1993 after a review of 244 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 - K924649

510(k) Number K924649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1992
Decision Date May 17, 1993
Days to Decision 244 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
104d slower than avg
Panel avg: 140d · This submission: 244d
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 K924649.
VENTI-GENTLE-HALER(TM)
K933915 · Vortran Medical Technology 1, Inc. · Oct 1993
STERI-CATH MDI
K923559 · Concord/Portex · Oct 1993
AEROSOL CHARGING ADAPTOR (FOR USE W/MININEB ONLY)
K924667 · Vortran Medical Technology 1, Inc. · Aug 1993
DEVILBISS MODEL 5650 PULMO-AIDE
K923888 · Devilbiss Health Care, Inc. · Feb 1993
PRECISION MIST COMPRESSOR
K923324 · Precision Medical, Inc. · Jan 1993
MICROFLOW
K924684 · Mountain Medical Equipment, Inc. · Dec 1992