Cleared Traditional

K984081 - EMOX

K984081 is an FDA 510(k) clearance for EMOX, manufactured by Emox 911 CC. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K984081 · Emox 911 CC · Anesthesiology device
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Mar 1999
Decision
121d
Days
Class 2
Risk

K984081 is an FDA 510(k) clearance for the EMOX. Classified as Generator, Oxygen, Portable within the CAW classification (a category for home-use oxygen therapy and respiratory devices), Class II - Special Controls.

Submitted by Emox 911 CC (Somerset West, ZA). The FDA issued a Cleared decision on March 17, 1999 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5440 - 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 Emox 911 CC devices

FDA 510(k) Submission Details - K984081

510(k) Number K984081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1998
Decision Date March 17, 1999
Days to Decision 121 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 140d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAW Device Classification - Class 2, Special Controls

Product Code CAW Generator, Oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5440
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 - CAW Generator, Oxygen, Portable

All 142
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K984081.
VENTURE IHO 100 HOME FILL COMPLETE HOME OXYGEN SYSTEM
K983627 · Invacare Corp. · Oct 1999
PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI
K993088 · Puritan Bennett Corp. · Oct 1999
FRESH AIR
K981047 · Colorado Medtech, Inc. · Sep 1999
MODIFICATION TO VENTURE IHO 100 COMPLETE HOME OXYGEN SYSTEM
K983777 · Invacare Corp. · Dec 1998
CANOGEN PORTABLE OXYGEN GENERATOR MODEL 615
K982243 · Canogen International , Ltd. · Nov 1998
TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000
K981078 · Transtracheal Systems · Jul 1998