# K012633: Respironics Heated Humidifier

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Feb 28, 2002 after 199 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 K915460 (1993). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915460: Heated Respiratory Humidifier HC100, Fisher & Paykel Electronics, Ltd. (1993) Summary page 1.
- (no number) REMstar Plus CPAP System/REMstar Heated Humidifier: named in the summary without a submission number

## Most influential descendants
- K030090: H2 Heated Humidifier (2003), 3 descendants of its own
- 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
- K031176: Invacare Polaris EX Heated Humidifier, Model ISP4000 (2004), 0 descendants of its own

## Indications for use
The Respironics Heated Humidifier is an accessory for CPAP and Bi-level systems to provide moisture to the patient circuit. It is intended for use with adult patients, in the home or hospital/institutional environment, who use mask- applied CPAP or Bi-level therapy for the treatment of Obstructive Sleep Apnea.

Source page: https://510kreport.com/device/K012633
Methodology: https://510kreport.com/methodology