Cleared Special

OMNI 5 TOTAL O2 DELIVERY SYSTEM (K091028) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K091028 · Respironics, Inc. · Anesthesiology device
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Jul 2009
Decision
104d
Days
Class 2
Risk

K091028 is an FDA 510(k) clearance for the OMNI 5 TOTAL O2 DELIVERY SYSTEM. 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 Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on July 23, 2009 after a review of 104 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Respironics, Inc. devices

Submission Details

510(k) Number K091028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2009
Decision Date July 23, 2009
Days to Decision 104 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 140d · This submission: 104d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 47
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K091028.
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HOMELOX
K081206 · Respironics, Inc. · Jul 2008
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K061261 · Respironics, Inc. · Jun 2006
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K043006 · Respironics, Inc. · Feb 2005