# K971129: Oxypure Portable Oxygen Generator

- Pathway: 510(k) (Traditional)
- Applicant: Arbor Research Corp.
- Decided: Jun 24, 1997 after 89 days
- Product code: CAW (Generator, Oxygen, Portable)
- Device class: 2
- Regulation: 21 CFR 868.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Oxygen generated by a portable oxygen generator is supplemental and should not be considered lfe-supporting. Supplemental oxygen is non-addictive but should only be used at the specific liter flow and number of hours prescribed by your physician. This device is intended for home use, in patients requiring supplemental oxygen for the pallative or therapeutic treatment of a variety of respiratory diseases, including emphysema, cheonic obstructive pulmonary disease, cardiopulmonary insufficiency and bronchiectasis. Federal faw restricts this device to sale by or on the order of a licensed physician, and is to be prescribed only after appropriate clinical evaluation or oximetry screening tests have been performed on the patient by the prescribing physician. This unit is not to be used for or with any life-supporting applications. Geriatric, pediatric, or any other patient unable to communicate discomfort while using this machine may require additional monitoring. In the event of an alarm or if you are experiencing any signs of patient discomfort, consult your physician immediately.

Source page: https://510kreport.com/device/K971129
Methodology: https://510kreport.com/methodology