Cleared Traditional

K880044 - OECO MEMBRANE OXYGNE & VAPOR ENRICHER M...

K880044 is the FDA 510(k) clearance for OECO MEMBRANE OXYGNE & VAPOR ENRICHER M... by Oxygen Enrichment Company, Ltd.. It is a Class 2 Anesthesiology device (product code CAW) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K880044 · Oxygen Enrichment Company, Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1988
Decision
82d
Days
Class 2
Risk

K880044 is an FDA 510(k) clearance for the OECO MEMBRANE OXYGNE & VAPOR ENRICHER MODEL OE-8. 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 Oxygen Enrichment Company, Ltd. (Schenectady, US). The FDA issued a Cleared decision on March 28, 1988 after a review of 82 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 Oxygen Enrichment Company, Ltd. devices

Submission Details

510(k) Number K880044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1988
Decision Date March 28, 1988
Days to Decision 82 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 140d · This submission: 82d
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 K880044.
PURITAN-BENNETT OXYGEN CONCENTRATION INDICATOR
K895177 · Puritan Bennett Corp. · Nov 1989
MODEL 590 OXYGEN CONCENTRATOR
K895141 · Puritan Bennett Corp. · Oct 1989
MOBILAIRE V OXYGEN CONCENTRATOR
K891488 · Invacare Corp. · May 1989
MOBILAIRE III P3 OXYGEN CONCENTRATOR
K851434 · Invacare Corp. · Jul 1985
PRIME AIRE O, MODEL PA02 2 O OXYGEN CONCENTRATOR
K851435 · Invacare Corp. · Jul 1985
PRIME AIRE O2 PLUS 2
K851437 · Invacare Corp. · Jul 1985