Cleared Traditional

K933915 - VENTI-GENTLE-HALER(TM)

K933915 is an FDA 510(k) clearance for VENTI-GENTLE-HALER(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 79-day FDA review.

K933915 · Vortran Medical Technology 1, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
79d
Days
Class 2
Risk

K933915 is an FDA 510(k) clearance for the VENTI-GENTLE-HALER(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 October 28, 1993 after a review of 79 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.

FDA 510(k) Submission Details - K933915

510(k) Number K933915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1993
Decision Date October 28, 1993
Days to Decision 79 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 140d · This submission: 79d
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 458
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K933915.
EZ-SPACER
K933090 · Airpharma, LLC · Feb 1994
AEROCHAMBER W/MASK, MODIFIED
K930574 · Monaghan Medical Corp. · Jan 1994
VENTSTREAM DRUG NEBULIZER
K933535 · Medic-Aid , Ltd. · Jan 1994
STERI-CATH MDI
K923559 · Concord/Portex · Oct 1993
MICRO MIST(TM) NEBULIZER
K930525 · Hudson Respiratory Care, Inc. · Sep 1993
PARI FILTER/VALVE SET
K926455 · Paul Ritzau Pari-Werk GmbH · Sep 1993
K933915 · VENTI-GENTLE-HALER(TM)
Download PDF FDA Summary Vortran Medical Techn…