Cleared Traditional

K852209 - DEVO/MC29 OXYGEN CONCENTRATOR MC29D

K852209 is an FDA 510(k) clearance for DEVO/MC29 OXYGEN CONCENTRATOR MC29D, manufactured by The Devilbiss Co.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K852209 · The Devilbiss Co. · Anesthesiology device
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Jun 1985
Decision
34d
Days
Class 2
Risk

K852209 is an FDA 510(k) clearance for the DEVO/MC29 OXYGEN CONCENTRATOR MC29D. 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 The Devilbiss Co. (Somerset, US). The FDA issued a Cleared decision on June 24, 1985 after a review of 34 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 The Devilbiss Co. devices

FDA 510(k) Submission Details - K852209

510(k) Number K852209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1985
Decision Date June 24, 1985
Days to Decision 34 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 140d · This submission: 34d
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 204
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K852209.
PRIME AIRE O2 PLUS 2
K851437 · Invacare Corp. · Jul 1985
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
ECONO MATE -OXYGEN CONCENTRATOR
K850253 · Mountain Medical Equipment, Inc. · Feb 1985
PREMIER O2 OXYGEN CONCENTRATOR
K844223 · Everest & Jennings, Inc. · Dec 1984