Cleared Traditional

K032818 - INOGEN ONE OXYGEN CONCENTRATOR

K032818 is an FDA 510(k) clearance for INOGEN ONE OXYGEN CONCENTRATOR, manufactured by Inogen, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K032818 · Inogen, Inc. · Anesthesiology device
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May 2004
Decision
246d
Days
Class 2
Risk

K032818 is an FDA 510(k) clearance for the INOGEN ONE OXYGEN CONCENTRATOR. 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 Inogen, Inc. (Goleta, US). The FDA issued a Cleared decision on May 13, 2004 after a review of 246 days - an extended review cycle.

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 Inogen, Inc. devices

FDA 510(k) Submission Details - K032818

510(k) Number K032818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2003
Decision Date May 13, 2004
Days to Decision 246 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 140d · This submission: 246d
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 92
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