Cleared Traditional

K850253 - ECONO MATE -OXYGEN CONCENTRATOR

K850253 is an FDA 510(k) clearance for ECONO MATE -OXYGEN CONCENTRATOR, manufactured by Mountain Medical Equipment, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K850253 · Mountain Medical Equipment, Inc. · Anesthesiology device
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Feb 1985
Decision
10d
Days
Class 2
Risk

K850253 is an FDA 510(k) clearance for the ECONO MATE -OXYGEN CONCENTRATOR. 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 Mountain Medical Equipment, Inc. (Littleton, US). The FDA issued a Cleared decision on February 1, 1985 after a review of 10 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.

View all Mountain Medical Equipment, Inc. devices

FDA 510(k) Submission Details - K850253

510(k) Number K850253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1985
Decision Date February 01, 1985
Days to Decision 10 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d faster than avg
Panel avg: 140d · This submission: 10d
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 120
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K850253.
MOBILAIRE II(P2A) OXYGEN CONCENTRATOR
K851438 · Invacare Corp. · Jul 1985
MOBILAIRE, PLA-01 OXYGEN CONCENTRATOR
K851439 · Invacare Corp. · Jul 1985
OXYGEN CONCENTRATOR
K850346 · Inspiron Corp. · Feb 1985
PREMIER O2 OXYGEN CONCENTRATOR
K844223 · Everest & Jennings, Inc. · Dec 1984
OXYGEN CONCENTRATOR
K844328 · Hospitak, Inc. · Dec 1984
ECONO MATE
K843715 · Mountain Medical Equipment, Inc. · Oct 1984