Cleared Traditional

K831819 - OXYGEN CONCENTRATOR RESPIRATORY SUPPOR

K831819 is an FDA 510(k) clearance for OXYGEN CONCENTRATOR RESPIRATORY SUPPOR, manufactured by Eagle Medical Equipment Co.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K831819 · Eagle Medical Equipment Co. · Anesthesiology device
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Nov 1983
Decision
169d
Days
Class 2
Risk

K831819 is an FDA 510(k) clearance for the OXYGEN CONCENTRATOR RESPIRATORY SUPPOR. 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 Eagle Medical Equipment Co. (Mchenry, US). The FDA issued a Cleared decision on November 22, 1983 after a review of 169 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.

View all Eagle Medical Equipment Co. devices

FDA 510(k) Submission Details - K831819

510(k) Number K831819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1983
Decision Date November 22, 1983
Days to Decision 169 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 140d · This submission: 169d
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 121
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K831819.
BUNN 1000 OXYGEN CONCENTRATOR
K841102 · The John Bunn Co. · Apr 1984
CATALOG 6400 OXYGEN CONCENTRATOR
K833938 · Hudson Oxygen Therapy Sales Co. · Dec 1983
MAX 02 OXYGEN CONCENTRATOR
K833500 · Mountain Medical Equipment, Inc. · Nov 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