Cleared Traditional

K912794 - ECONOMATE/PATRIOT

K912794 is an FDA 510(k) clearance for ECONOMATE/PATRIOT, manufactured by Foothills Medical Equipment, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K912794 · Foothills Medical Equipment, Inc. · Anesthesiology device
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Feb 1992
Decision
241d
Days
Class 2
Risk

K912794 is an FDA 510(k) clearance for the ECONOMATE/PATRIOT. 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 Foothills Medical Equipment, Inc. (Littleton, US). The FDA issued a Cleared decision on February 21, 1992 after a review of 241 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.

FDA 510(k) Submission Details - K912794

510(k) Number K912794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1991
Decision Date February 21, 1992
Days to Decision 241 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 140d · This submission: 241d
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 225
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K912794.
ALPINE V
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V-LINK
K903608 · GE Medical Systems · Oct 1990
ASPEN 3 OXYGEN CONCENTRATOR
K902890 · Mountain Medical Equipment, Inc. · Jul 1990