Cleared Traditional

PORTABLE OXYGEN GENERATOR SYSTEM (K062153) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K062153 · Molecular Products , Ltd. · Anesthesiology device
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Nov 2006
Decision
117d
Days
Class 2
Risk

K062153 is an FDA 510(k) clearance for the PORTABLE OXYGEN GENERATOR 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 Molecular Products , Ltd. (Bonita Springs, US). The FDA issued a Cleared decision on November 21, 2006 after a review of 117 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. 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 Molecular Products , Ltd. devices

Submission Details

510(k) Number K062153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2006
Decision Date November 21, 2006
Days to Decision 117 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
23d faster than avg
Panel avg: 140d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 48
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K062153.
SIMPLYGO PORTABLE OXYGEN CONCENTRATOR
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K061261 · Respironics, Inc. · Jun 2006
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K043006 · Respironics, Inc. · Feb 2005
V-LINK
K903608 · GE Medical Systems · Oct 1990