Cleared Special

K140211 - ULTRASONIC MESH NEBULIZER

K140211 is an FDA 510(k) clearance for ULTRASONIC MESH NEBULIZER, manufactured by Foshan Gaunying Electronics Co., Ltd.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Special 510(k) pathway after a 122-day FDA review.

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.

FDA 510(k) Submission Details - K140211

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 140d · This submission: 122d
Pathway characteristics
Modification to existing cleared device.

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 Peers - CAF Nebulizer (direct Patient Interface)

All 441
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K140211.
COMP A-I-R
K141140 · Omron Healthcare, Inc. · Sep 2014
RESPICONNECT ADAPTER
K140919 · Trudell Medical Int'L · Aug 2014
BREEZE NEBULIZER (NBR-10X)
K133105 · Digio2 International Co., Ltd. · Jun 2014
PROPELLER SYSTEM - MODEL 2
K140638 · Reciprocal Labs Corporation · May 2014
SMARTTOUCH
K133951 · Nexus6, Ltd. · Apr 2014
ULTRASONIC MESH NEBULIZER
K132247 · Foshan Gaunying Electronics Co., Ltd. · Jan 2014