Cleared Traditional

K971889 - CHAD TOTAL O2 DELIVERY SYSTEM

K971889 is an FDA 510(k) clearance for CHAD TOTAL O2 DELIVERY SYSTEM, manufactured by Chad Therapeutics, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K971889 · Chad Therapeutics, Inc. · Anesthesiology device
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Nov 1997
Decision
180d
Days
Class 2
Risk

K971889 is an FDA 510(k) clearance for the CHAD TOTAL O2 DELIVERY 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 Chad Therapeutics, Inc. (Chatsworth, US). The FDA issued a Cleared decision on November 17, 1997 after a review of 180 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.

FDA 510(k) Submission Details - K971889

510(k) Number K971889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1997
Decision Date November 17, 1997
Days to Decision 180 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
40d slower than avg
Panel avg: 140d · This submission: 180d
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 224
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K971889.
CANOGEN PORTABLE OXYGEN GENERATOR MODEL 615
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INNOSAN TRAVELAIR S PLUS PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853 (WITH AC POWER SUPPLY ACCESSORY)
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OXLIFE EXCELL OXYGEN CONCENTRATORS
K971964 · Oxlife, Inc. · Aug 1997
OXYPURE PORTABLE OXYGEN GENERATOR
K971129 · Arbor Research Corp. · Jun 1997