Cleared Traditional

K170916 - Portable Nebulizer

K170916 is an FDA 510(k) clearance for Portable Nebulizer, manufactured by Microbase Technology Corporation. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K170916

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

Microbase Technology Corporation C/O Promedic, LLC
Paul Dryden

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CAF Nebulizer (direct Patient Interface)

All 349
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
InnoSpire Go
K170853 · Respironics Respiratory Drug Delivery (Uk) , Ltd. · Nov 2017
The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS)
K161586 · Shenzhen Homed Medical Device Co., Ltd. · Sep 2017
SmartTouch
K163485 · Adherium (Nz), Ltd. · Aug 2017