Cleared Traditional

MC 300R* Nebulizer (K173825) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173825 · Trudell Medical International · Anesthesiology device
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May 2018
Decision
135d
Days
Class 2
Risk

K173825 is an FDA 510(k) clearance for the MC 300R* Nebulizer. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Trudell Medical International (London, CA). The FDA issued a Cleared decision on May 2, 2018 after a review of 135 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 International devices

Submission Details

510(k) Number K173825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2017
Decision Date May 02, 2018
Days to Decision 135 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
5d faster than avg
Panel avg: 140d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 75
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K173825.
Propeller Sensor for Neohaler
K180770 · Reciprocal Labs Corporation · Aug 2018
Smartinhaler
K180407 · Adherium (Nz), Ltd. · Jul 2018
HOMED Mesh Nebulizer
K170886 · Shenzhen Homed Medical Device Co., Ltd. · Jun 2018
SmartTouch
K173310 · Adherium (Nz), Ltd. · Mar 2018
MC 300* Nebulizer
K173367 · Trudell Medical International · Feb 2018
CLEVER TD-7001NEBULIZER
K122060 · Taidoc Technology Corporation · Mar 2013