# K042184: Goodknight H20, Model M-114600-00

- Pathway: 510(k) (Traditional)
- Applicant: Mallinckrodt Developpement France
- Decided: Jan 10, 2005 after 151 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: 3 generations back to K915460 (1993). 3 ancestors in all.
2 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)
- K030090: H2 Heated Humidifier, Respironics, Inc. (2003) Summary page 1.

## Most influential descendants
- 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 Puritan Bennett GoodKnight H20 is an accessory intended to warm and add moisture to the inspiratory gas flow for administration to a patient undergoing CPAP or bi-level therapy. It is intended for use with adult patients receiving CPAP or Bi-level therapy for the treatment of Obstructive Sleep Apnea in the homecare and hospital environments.

Source page: https://510kreport.com/device/K042184
Methodology: https://510kreport.com/methodology