Cleared Traditional

K864466 - OMRON ULTRASONIC NEBULIZER MODEL NE-UO5

K864466 is an FDA 510(k) clearance for OMRON ULTRASONIC NEBULIZER MODEL NE-UO5, manufactured by Omron Tateisi Electronics Co.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K864466 · Omron Tateisi Electronics Co. · Anesthesiology device
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Mar 1987
Decision
134d
Days
Class 2
Risk

K864466 is an FDA 510(k) clearance for the OMRON ULTRASONIC NEBULIZER MODEL NE-UO5. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Omron Tateisi Electronics Co. (Tokyo, 105 Japan, JP). The FDA issued a Cleared decision on March 26, 1987 after a review of 134 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. 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 Omron Tateisi Electronics Co. devices

FDA 510(k) Submission Details - K864466

510(k) Number K864466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1986
Decision Date March 26, 1987
Days to Decision 134 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 140d · This submission: 134d
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 384
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K864466.
RESPIRGARD II NEBULIZER SYSTEM
K874395 · Marquest Medical Products, Inc. · Dec 1987
HOYER SOLVET
K873395 · Infrasonics Corp. · Oct 1987
SERVO NEBULIZER 945 SIEMENS-ELEMA AB
K871293 · Siemens Elema AB · May 1987
NEBULAIRE (IRC 1040) NEBULIZER PUMP
K851436 · Invacare Corp. · Jul 1985
VARIABLE NEBULIZER HEATER
K851074 · Travenol Laboratories, S.A. · Jun 1985
SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN
K834077 · Airlife, Inc. · Dec 1983