Cleared Traditional

K170916 - Portable Nebulizer

K170916 is the FDA 510(k) clearance for Portable Nebulizer by Microbase Technology Corporation. It is a Class 2 Anesthesiology device (product code CAF) cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K170916 · Microbase Technology Corporation · Anesthesiology device
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Nov 2017
Decision
244d
Days
Class 2
Risk

K170916 is an FDA 510(k) clearance for the Portable Nebulizer. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Microbase Technology Corporation (Bade District, Taoyuan City, TW). The FDA issued a Cleared decision on November 28, 2017 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 Microbase Technology Corporation devices

Submission Details

510(k) Number K170916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2017
Decision Date November 28, 2017
Days to Decision 244 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
104d slower than avg
Panel avg: 140d · This submission: 244d
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 135
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K170916.
MC 300R* Nebulizer
K173825 · Trudell Medical International · May 2018
SmartTouch
K173310 · Adherium (Nz), Ltd. · Mar 2018
MC 300* Nebulizer
K173367 · Trudell Medical International · Feb 2018
AirLife Misty Finity Nebulizer
K153748 · Care Fusion · May 2017
RTC 26-C Inline Aerosol Adapter
K162753 · Instrumentation Industries, Inc. · Feb 2017
Hudson RCI AquaPak Sterile Prefilled Nebulizers
K153010 · Teleflexmedical, Inc. · Jul 2016