Cleared Traditional

K933081 - OXLIFE OXYGEN CONCENTRATOR

K933081 is an FDA 510(k) clearance for OXLIFE OXYGEN CONCENTRATOR, manufactured by Oxlife, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 496-day FDA review.

K933081 · Oxlife, Inc. · Anesthesiology device
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Nov 1994
Decision
496d
Days
Class 2
Risk

K933081 is an FDA 510(k) clearance for the OXLIFE 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 Oxlife, Inc. (N. Ft. Myers, US). The FDA issued a Cleared decision on November 1, 1994 after a review of 496 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

FDA 510(k) Submission Details - K933081

510(k) Number K933081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1993
Decision Date November 01, 1994
Days to Decision 496 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
356d slower than avg
Panel avg: 140d · This submission: 496d
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 234
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K933081.
3 LPM OXYGEN CONCENTRATOR
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K942082 · Dynotec Corp. · Dec 1994
SBS MODEL 1615
K924565 · Stand-By-Systems, Inc. · Sep 1994
MINIOX IA OXYGEN ANALYZER
K935370 · Minesafety Appliances Co. · Aug 1994
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K942357 · Healthdyne, Inc. · May 1994
K933081 · OXLIFE OXYGEN CONCENTRATOR
Download PDF Oxlife, Inc.