# K030090: H2 Heated Humidifier

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Jan 24, 2003 after 14 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.
3 later devices descend from it; 1 cites it directly.
0 of 6 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) Summary page 1.
- K915460: Heated Respiratory Humidifier HC100, Fisher & Paykel Electronics, Ltd. (1993) Summary page 1.

## Most influential descendants
- K042184: Goodknight H20, Model M-114600-00 (2005), 2 descendants of its own
- K080439: Sandman Info Without Humidifier/ Sandman Auto Without Humidifier, Model M-114801-114802-US; Sandman Info with Intergrate (2008), 1 descendant of its own
- K082237: Puritan Bennett, Sandman Duo and Sandman Duo ST (2008), 0 descendants of its own

## Indications for use
The Respironics H2 Heated Humidifier is an accessory for positive pressure ventilation systems to provide moisture to the patient circuit. It is intended for use with adult patients (> 30 kg), in the home or hospital/institutional environment, who use mask-applied positive pressure ventilation.

Source page: https://510kreport.com/device/K030090
Methodology: https://510kreport.com/methodology