Cleared Traditional

K850066 - OMNIMED NASAL OXYGEN CANNULA

K850066 is an FDA 510(k) clearance for OMNIMED NASAL OXYGEN CANNULA, manufactured by Omni Intl., Inc.. The device is a Class 1 Anesthesiology device with product code CAT cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K850066 · Omni Intl., Inc. · Anesthesiology device
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Jan 1985
Decision
16d
Days
Class 1
Risk

K850066 is an FDA 510(k) clearance for the OMNIMED NASAL OXYGEN CANNULA. Classified as Cannula, Nasal, Oxygen (product code CAT), Class I - General Controls.

Submitted by Omni Intl., Inc. (Palm Springs, US). The FDA issued a Cleared decision on January 24, 1985 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5340 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Omni Intl., Inc. devices

FDA 510(k) Submission Details - K850066

510(k) Number K850066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1985
Decision Date January 24, 1985
Days to Decision 16 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d faster than avg
Panel avg: 140d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

CAT Device Classification - Class 1, General Controls

Product Code CAT Cannula, Nasal, Oxygen
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5340
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CAT Cannula, Nasal, Oxygen

All 20
Devices cleared under the same product code (CAT) and FDA review panel - the closest regulatory comparables to K850066.
OXYGEN CANNULA EAR WRAP (STYLE B)
K863432 · Salter Labs · Sep 1986
UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS)
K860535 · Andover Medical, Inc. · Apr 1986
NASAL CANNULA W/2M & 5M TUBING
K860872 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
PHARMA-PLAST NASAL OXYGEN CANNULA
K843467 · Zimmar Consulting , Ltd. · Nov 1984
CHAD ADJUSTABLE CANNULA
K842968 · Chad Therapeutics, Inc. · Aug 1984
ARGYLE NASAL CANNULA
K833127 · Sherwood Medical Co. · Nov 1983