# K031176: Invacare Polaris EX Heated Humidifier, Model ISP4000

- Pathway: 510(k) (Traditional)
- Applicant: Invacare Corp.
- Decided: Mar 25, 2004 after 346 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K915460 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012633: Respironics Heated Humidifier, Respironics, Inc. (2002)

## Indications for use
The Invacare Polaris EX Heated Humidifier is an accessory for the Invacare Polaris EX CPAP, a prescription device for use in the home, that is used by an adult (>30 kg) who has been diagnosed with Obstructive Sleep Apnea (OSA). The intended function and use of the heated humidifier is to provide moisture to the patient circuit in order to improve patient comfort.

Source page: https://510kreport.com/device/K031176
Methodology: https://510kreport.com/methodology