Cleared Traditional

HOME-AWAY SYSTEM (K004047) - FDA 510(k) Clearance

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

K004047 · In-X Corp. · Anesthesiology device
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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.

View all In-X Corp. devices

Submission Details

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
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.

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 56
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K004047.
MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600
K043006 · Respironics, Inc. · Feb 2005
VENTURE HOMEFILL II WITH OXYGEN CONSERVER
K021685 · Invacare Corp. · Jul 2002
INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02
K020386 · Invacare Corp. · Jul 2002
VENTURE HOME FILL II, MODEL IOH 200
K003939 · Invacare Corp. · Mar 2001
VENTURE IHO 100 HOME FILL COMPLETE HOME OXYGEN SYSTEM
K983627 · Invacare Corp. · Oct 1999
MODIFICATION TO VENTURE IHO 100 COMPLETE HOME OXYGEN SYSTEM
K983777 · Invacare Corp. · Dec 1998