Cleared Traditional

K133105 - BREEZE NEBULIZER (NBR-10X)

K133105 is an FDA 510(k) clearance for BREEZE NEBULIZER (NBR-10X), manufactured by Digio2 International Co., Ltd.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K133105 · Digio2 International Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
267d
Days
Class 2
Risk

K133105 is an FDA 510(k) clearance for the BREEZE NEBULIZER (NBR-10X). Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Digio2 International Co., Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on June 24, 2014 after a review of 267 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.

FDA 510(k) Submission Details - K133105

510(k) Number K133105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2013
Decision Date June 24, 2014
Days to Decision 267 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
127d slower than avg
Panel avg: 140d · This submission: 267d
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 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 K133105.
AERONEB SOLO
K133360 · Aerogen, Ltd. · Oct 2014
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RESPICONNECT ADAPTER
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ULTRASONIC MESH NEBULIZER
K140211 · Foshan Gaunying Electronics Co., Ltd. · May 2014
PROPELLER SYSTEM - MODEL 2
K140638 · Reciprocal Labs Corporation · May 2014
SMARTTOUCH
K133951 · Nexus6, Ltd. · Apr 2014