Cleared Special

K113111 - CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION

K113111 is an FDA 510(k) clearance for CHAD THERAPEUTIC EVOLUTION ELECTRONIC O..., manufactured by Inovo, Inc.. The device is a Class 2 Anesthesiology device with product code NFB cleared through the Special 510(k) pathway after a 49-day FDA review.

K113111 · Inovo, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
49d
Days
Class 2
Risk

K113111 is an FDA 510(k) clearance for the CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Inovo, Inc. (Naples, US). The FDA issued a Cleared decision on December 8, 2011 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K113111

510(k) Number K113111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2011
Decision Date December 08, 2011
Days to Decision 49 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
91d faster than avg
Panel avg: 140d · This submission: 49d
Pathway characteristics
Modification to existing cleared device.

NFB Device Classification - Class 2, Special Controls

Product Code NFB Conserver, Oxygen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - NFB Conserver, Oxygen

All 62
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K113111.
Apogee
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