Cleared Traditional

K823172 - MEDOX OXYGEN SYSTEM

K823172 is the FDA 510(k) clearance for MEDOX OXYGEN SYSTEM by Mepecc Intl.. It is a Class 2 Anesthesiology device (product code CAW) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K823172 · Mepecc Intl. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1983
Decision
92d
Days
Class 2
Risk

K823172 is an FDA 510(k) clearance for the MEDOX OXYGEN 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 Mepecc Intl. (Walker, US). The FDA issued a Cleared decision on February 1, 1983 after a review of 92 days - within the typical 510(k) review window.

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.

View all Mepecc Intl. devices

Submission Details

510(k) Number K823172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1982
Decision Date February 01, 1983
Days to Decision 92 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 140d · This submission: 92d
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 70
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K823172.
MOBILAIRE II(P2A) OXYGEN CONCENTRATOR
K851438 · Invacare Corp. · Jul 1985
MOBILAIRE, PLA-01 OXYGEN CONCENTRATOR
K851439 · Invacare Corp. · Jul 1985
COMPANION 492 OXYGEN CONCENTRATOR
K843243 · Puritan Bennett Corp. · Aug 1984
OXYGEN CONCENTRATOR
K823524 · C.R. Bard, Inc. · Dec 1982
LINDE OXYGEN CONCENTRATOR LOC-II
K791437 · Union Carbide Corp. · Sep 1979
LINDE OXYGEN CONCENTRATOR MODEL LOC-HC
K791043 · Union Carbide Corp. · Jun 1979