Cleared Special

K140211 - ULTRASONIC MESH NEBULIZER (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K140211 · Foshan Gaunying Electronics Co., Ltd. · Anesthesiology device
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May 2014
Decision
122d
Days
Class 2
Risk

K140211 is an FDA 510(k) clearance for the ULTRASONIC MESH NEBULIZER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Foshan Gaunying Electronics Co., Ltd. (Bonita Springs, US). The FDA issued a Cleared decision on May 30, 2014 after a review of 122 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Foshan Gaunying Electronics Co., Ltd. devices

Submission Details

510(k) Number K140211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2014
Decision Date May 30, 2014
Days to Decision 122 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 139d · This submission: 122d
Pathway characteristics
Modification to existing cleared device.

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 506
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