Cleared Traditional

POGS, MODEL 33C (K063454) - FDA 510(k) Clearance

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

K063454 · On Site Gas Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
175d
Days
Class 2
Risk

K063454 is an FDA 510(k) clearance for the POGS, MODEL 33C. 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 On Site Gas Systems, Inc. (Newington, US). The FDA issued a Cleared decision on May 9, 2007 after a review of 175 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 On Site Gas Systems, Inc. devices

Submission Details

510(k) Number K063454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2006
Decision Date May 09, 2007
Days to Decision 175 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
35d slower than avg
Panel avg: 140d · This submission: 175d
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 K063454.
SIMPLYGO PORTABLE OXYGEN CONCENTRATOR
K111885 · Respironics, Inc. · Nov 2011
OMNI 5 TOTAL O2 DELIVERY SYSTEM
K091028 · Respironics, Inc. · Jul 2009
HOMELOX
K081206 · Respironics, Inc. · Jul 2008
L4 OXYGEN CONCENTRATOR
K061261 · Respironics, Inc. · Jun 2006
MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600
K043006 · Respironics, Inc. · Feb 2005
V-LINK
K903608 · GE Medical Systems · Oct 1990