Cleared Traditional

K123614 - SOLARYS VENTILATOR AEROSOL DELIVERY SYS...

K123614 is an FDA 510(k) clearance for SOLARYS VENTILATOR AEROSOL DELIVERY SYS..., manufactured by Trudell Medical Intl.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K123614 · Trudell Medical Intl. · Anesthesiology device
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Mar 2013
Decision
108d
Days
Class 2
Risk

K123614 is an FDA 510(k) clearance for the SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS). Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Trudell Medical Intl. (London, CA). The FDA issued a Cleared decision on March 11, 2013 after a review of 108 days - within the typical 510(k) review window.

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 Trudell Medical Intl. devices

FDA 510(k) Submission Details - K123614

510(k) Number K123614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2012
Decision Date March 11, 2013
Days to Decision 108 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 140d · This submission: 108d
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 224
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