Cleared Abbreviated

K090681 - TANSCU O2

K090681 is an FDA 510(k) clearance for TANSCU O2, manufactured by Electrochemical Oxygen Concepts, Inc.. The device is a Class 2 General & Plastic Surgery device with product code KPJ cleared through the Abbreviated 510(k) pathway after a 149-day FDA review.

K090681 · Electrochemical Oxygen Concepts, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
149d
Days
Class 2
Risk

K090681 is an FDA 510(k) clearance for the TANSCU O2. Classified as Chamber, Oxygen, Topical, Extremity (product code KPJ), Class II - Special Controls.

Submitted by Electrochemical Oxygen Concepts, Inc. (Lake Bluff, US). The FDA issued a Cleared decision on August 12, 2009 after a review of 149 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5650 - the FDA general and plastic surgery device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Electrochemical Oxygen Concepts, Inc. devices

FDA 510(k) Submission Details - K090681

510(k) Number K090681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2009
Decision Date August 12, 2009
Days to Decision 149 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 115d · This submission: 149d
Pathway characteristics
Standards-based clearance path.

KPJ Device Classification - Class 2, Special Controls

Product Code KPJ Chamber, Oxygen, Topical, Extremity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5650
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - KPJ Chamber, Oxygen, Topical, Extremity

All 8
Devices cleared under the same product code (KPJ) and FDA review panel - the closest regulatory comparables to K090681.
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