# K041819: Goodknight 425, Modelm-114500-00

- Pathway: 510(k) (Special)
- Applicant: Mallinckrodt Developpement France
- Decided: Jul 22, 2004 after 16 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K903764 (1990). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020886: Purtian Bennett, Good Knight 420G Model M-113900-US; Purtan Bennett, Goodknight 420S Model M-113903-US, Tyco Healthcare Nancy (2002) Summary page 1.

## Most influential descendants
- K050072: Goodknight 425ST (2005), 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 425 is indicated for use in treating obstructive sleep apnea (OSA) in spontaneously breathing patients weighing over 30 kg within a homecare and hospital environment.

Source page: https://510kreport.com/device/K041819
Methodology: https://510kreport.com/methodology