Cleared Traditional

K833500 - MAX 02 OXYGEN CONCENTRATOR

K833500 is an FDA 510(k) clearance for MAX 02 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 55-day FDA review.

K833500 · Mountain Medical Equipment, Inc. · Anesthesiology device
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Nov 1983
Decision
55d
Days
Class 2
Risk

K833500 is an FDA 510(k) clearance for the MAX 02 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. (Mchenry, US). The FDA issued a Cleared decision on November 29, 1983 after a review of 55 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 - K833500

510(k) Number K833500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1983
Decision Date November 29, 1983
Days to Decision 55 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
85d faster than avg
Panel avg: 140d · This submission: 55d
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 K833500.
CRITERION I
K834274 · Timeter Instrument Corp. · Apr 1984
BUNN 1000 OXYGEN CONCENTRATOR
K841102 · The John Bunn Co. · Apr 1984
CATALOG 6400 OXYGEN CONCENTRATOR
K833938 · Hudson Oxygen Therapy Sales Co. · Dec 1983
OXYGEN CONCENTRATOR
K823524 · C.R. Bard, Inc. · Dec 1982
MODEL BX-3000 OXYGEN CONCENTRATOR
K822871 · Healthdyne, Inc. · Oct 1982
MODEL #6200 OXYGEN CONCENTRATOR
K822889 · Hudson Oxygen Therapy Sales Co. · Oct 1982