# K031064: Invacare Polaris EX Cpap, Model ISP3000

- Pathway: 510(k) (Traditional)
- Applicant: Invacare Corp.
- Decided: Mar 12, 2004 after 344 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K953930 (1996). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021861: Remstar Pro with C-Flex Cpap System, Respironics, Inc. (2002) Summary page 1.
- K982242: Invacare Cpap, Invacare Corp. (1999) Summary page 1.

## Indications for use
The intended use of the Invacare Polaris EX CPAP is to provide positive airway pressure therapy to adult patients (>30 kg) for treatment of Obstructive Sleep Apnea (OSA)

Source page: https://510kreport.com/device/K031064
Methodology: https://510kreport.com/methodology