Cleared Abbreviated

TANSCU O2 (K090681) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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.