Cleared Traditional

K875134 - OMRON ULTRASONIC NEBULIZER NE-U06

K875134 is an FDA 510(k) clearance for OMRON ULTRASONIC NEBULIZER NE-U06, manufactured by Nidek, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 356-day FDA review.

K875134 · Nidek, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1988
Decision
356d
Days
Class 2
Risk

K875134 is an FDA 510(k) clearance for the OMRON ULTRASONIC NEBULIZER NE-U06. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Nidek, Inc. (Birmingham, US). The FDA issued a Cleared decision on December 5, 1988 after a review of 356 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Nidek, Inc. devices

FDA 510(k) Submission Details - K875134

510(k) Number K875134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1987
Decision Date December 05, 1988
Days to Decision 356 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
216d slower than avg
Panel avg: 140d · This submission: 356d
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 375
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K875134.
ADJUSTABLE ENTRAINMENT NEBULIZER
K882936 · Automatic Liquid Packaging, Inc. · Jan 1989
NEBULIZER HEATER
K882935 · Automatic Liquid Packaging, Inc. · Dec 1988
UNIT DOSE 3% SODIUM CHLORIDE SOLUTION FOR INHALA.
K884359 · Automatic Liquid Packaging, Inc. · Dec 1988
AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER
K883964 · Baxter Healthcare Corp · Nov 1988
MICROCIRRUS MEDICAL NEBULIZER
K881935 · Dhd Medical Products Div. Diemolding Corp. · Jun 1988
INSPIRON NEBULO BASIC EXTERNAL HEATER
K880304 · Intertech Resources, Inc. · Mar 1988