Cleared Traditional

K062263 - OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22

K062263 is an FDA 510(k) clearance for OMRON MICRO-AIR VIBRATING MESH NEBULIZER, manufactured by Omron Healthcare, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K062263 · Omron Healthcare, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
203d
Days
Class 2
Risk

K062263 is an FDA 510(k) clearance for the OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Omron Healthcare, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on February 23, 2007 after a review of 203 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 - K062263

510(k) Number K062263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2006
Decision Date February 23, 2007
Days to Decision 203 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
63d slower than avg
Panel avg: 140d · This submission: 203d
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 K062263.
HSINER NEBULIZER BOTTLE
K070948 · Hsiner · Apr 2007
FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB
K062014 · Flaem Nuova S.P.A. · Mar 2007
DELUXE NEBULIZER
K063449 · Access Point Medical, LLC · Mar 2007
C300 SERIES AIR NEBULIZER COMPRESSOR
K062952 · Choice Smart Health Care Co. , Ltd. · Feb 2007
SIDESTREAM PLUS
K062689 · Respironics , Ltd. · Feb 2007
AG-EDGE, MODEL 91200
K063103 · Medel S.P.A. · Jan 2007