Cleared Traditional

K123614 - SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)

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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 441
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K123614.
CLEVER TD-7001NEBULIZER
K122060 · Taidoc Technology Corporation · Mar 2013
ULTRASONIC NEBULIZER (MESH TYPE)
K121520 · K-Jump Health Co., Ltd. · Mar 2013
PULMOSAL
K130091 · Pharmacaribe · Mar 2013
U-RIGHT COMPRESSOR NEBULIZER
K121969 · Taidoc Technology Corporation · Feb 2013
HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100
K122857 · Pegasus Research Corp. · Nov 2012
ULTRASONIC NEBULIZER
K121154 · Foshan Gaunying Electronics Co., Ltd. · Aug 2012