Cleared Traditional

K180871 - Portable Nebulizer

K180871 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 164-day FDA review.

K180871 · Microbase Technology Corporation · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2018
Decision
164d
Days
Class 2
Risk

K180871 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 September 14, 2018 after a review of 164 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 - K180871

510(k) Number K180871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2018
Decision Date September 14, 2018
Days to Decision 164 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
24d slower than avg
Panel avg: 140d · This submission: 164d
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 K180871.
Hailie Sensor
K182638 · Adherium (Nz), Ltd. · Jun 2019
Hailie Sensor
K182573 · Adherium (Nz), Ltd. · Jun 2019
Hailie Sensor
K181405 · Adherium (Nz), Ltd. · Dec 2018
Intelligent Mesh Nebulizer
K171549 · Qingdao Future Medical Technology Co., Ltd. · Aug 2018
Propeller Sensor for Neohaler
K180770 · Reciprocal Labs Corporation · Aug 2018
Smartinhaler
K180407 · Adherium (Nz), Ltd. · Jul 2018