Cleared Traditional

K875134 - OMRON ULTRASONIC NEBULIZER NE-U06 (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
217d slower than avg
Panel avg: 139d · This submission: 356d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 506
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K875134.
eRapid with eTrack System
K251572 · Pari Respiratory Equipment, Inc. · Dec 2025
Mesh Nebulizer (H6)
K251659 · Qingdao Future Medical Technology Co., Ltd. · Nov 2025
Portable mesh nebulizer (JM821)
K244035 · Shenzhen Jermei Medical Device Technology Co., Ltd. · Sep 2025
Compressor Nebulizer (NB-1100)
K243468 · Joytech Healthcare Co. , Ltd. · Jul 2025
HeroTracker Sense
K250022 · Voluntis · Jun 2025
AdheResp Smart Breath-actuated Mesh Nebulizer
K250583 · Hcmed Innovations Co., Ltd. · Jun 2025