Cleared Traditional

K004047 - HOME-AWAY SYSTEM

K004047 is an FDA 510(k) clearance for HOME-AWAY SYSTEM, manufactured by In-X Corp.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 354-day FDA review.

K004047 · In-X Corp. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
354d
Days
Class 2
Risk

K004047 is an FDA 510(k) clearance for the HOME-AWAY 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 In-X Corp. (Denver, US). The FDA issued a Cleared decision on December 18, 2001 after a review of 354 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K004047

510(k) Number K004047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2000
Decision Date December 18, 2001
Days to Decision 354 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
214d slower than avg
Panel avg: 140d · This submission: 354d
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 282
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K004047.
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
ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM
K014078 · On Site Gas Systems, Inc. · Jan 2002
TOTAL O2
K013472 · Chad Therapeutics, Inc. · Nov 2001
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
K011844 · Merits Health Products., Inc. · Aug 2001
INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM
K003472 · Sequal Technologies, Inc. · Jun 2001
K004047 · HOME-AWAY SYSTEM
Download PDF FDA Summary In-X Corp.