Cleared Traditional

K014078 - ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM

K014078 is an FDA 510(k) clearance for ON SITE GAS SYSTEMS PORTABLE OXYGEN GEN..., manufactured by On Site Gas Systems, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K014078 · On Site Gas Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
28d
Days
Class 2
Risk

K014078 is an FDA 510(k) clearance for the ON SITE GAS SYSTEMS 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 On Site Gas Systems, Inc. (New Britain, US). The FDA issued a Cleared decision on January 8, 2002 after a review of 28 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K014078

510(k) Number K014078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2001
Decision Date January 08, 2002
Days to Decision 28 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 140d · This submission: 28d
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 224
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K014078.
PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM (PVOCS)
K013223 · Litton Systems, Inc. · Feb 2002
MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
K014301 · Merits Health Products Co., Ltd. · Feb 2002
HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009
K012037 · Airsep Corp. · Jan 2002
HOME-AWAY SYSTEM
K004047 · In-X Corp. · Dec 2001
TOTAL O2
K013472 · Chad Therapeutics, Inc. · Nov 2001
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
K011844 · Merits Health Products., Inc. · Aug 2001