# K993088: Puritan-Bennett Aeris 590 Oxygen Concentrator with Oci

- Pathway: 510(k) (Special)
- Applicant: Puritan Bennett Corp.
- Decided: Oct 8, 1999 after 22 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
Longest line of descent: 1 generation back to K895141 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895141: Model 590 Oxygen Concentrator, Puritan Bennett Corp. (1989) Summary page 1.

## Indications for use
The Puritan-Bennett Aeris 590 oxygen concentrator with OCI is intended to provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe. It is intended to be used with both pediatric and adult patients. It is not intended as life sustaining or life supporting device. The device has no contraindications.

Source page: https://510kreport.com/device/K993088
Methodology: https://510kreport.com/methodology