# K050990: Remrest Heated Humidifier

- Pathway: 510(k) (Traditional)
- Applicant: Medical Industries America, Inc.
- Decided: May 2, 2005 after 13 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: 1 generation back to K010263 (2001). 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)
- K003973: Respiratory Humidifier, Model HC150, Fisher & Paykel Healthcare, Ltd. (2001) Summary page 1.
- K010263: Remstar Plus Cpap System, Respironics, Inc. (2001) Summary page 2.

## Indications for use
The [vo Heated Humidifier is intended to warm and add moisture to the breathing gases for administration to a patient. It is used for patients requiring Continuous Positive Airway Pressure (CPAP) therapy for the treatment of Obstructive Sleep Apnea. The addition of heated humidification to tfis therapy relieves the drying and irritating effects on the patient airways, which may arise from the use of a CPAP system. Use only with RemiRest 900 series CPAP devices. It is portable and is intended to be used in the home, hospital, and institutional settings.

Source page: https://510kreport.com/device/K050990
Methodology: https://510kreport.com/methodology