Cleared Traditional Expedited

K120566 - O2PAK OXYGEN GENERATOR

K120566 is an FDA 510(k) clearance for O2PAK OXYGEN GENERATOR, manufactured by Pacific Precision Products. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K120566 · Pacific Precision Products · Anesthesiology device
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Jul 2012
Decision
148d
Days
Class 2
Risk

K120566 is an FDA 510(k) clearance for the O2PAK OXYGEN GENERATOR. 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 Pacific Precision Products (Irvine, US). The FDA issued a Cleared decision on July 24, 2012 after a review of 148 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 Pacific Precision Products devices

FDA 510(k) Submission Details - K120566

510(k) Number K120566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2012
Decision Date July 24, 2012
Days to Decision 148 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
8d slower than avg
Panel avg: 140d · This submission: 148d
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 121
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K120566.
Oxygen Concentrator
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K160630 · Invacare Corporation · Sep 2016
SIMPLYGO PORTABLE OXYGEN CONCENTRATOR
K111885 · Respironics, Inc. · Nov 2011
PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150
K103563 · Precision Medical, Inc. · Jul 2011
MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY
K091716 · Merits Health Products Co., Ltd. · Apr 2010