# K050072: Goodknight 425ST

- Pathway: 510(k) (Special)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Jun 13, 2005 after 152 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: 6 generations back to K903764 (1990). 9 ancestors in all.
1 later device descends from it; 1 cites 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)
- K041819: Goodknight 425, Modelm-114500-00, Mallinckrodt Developpement France (2004) Summary page 1.

## Most influential descendants
- K082237: Puritan Bennett, Sandman Duo and Sandman Duo ST (2008), 0 descendants of its own

## Indications for use
The Puritan Bennett GoodKnight 425ST 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/K050072
Methodology: https://510kreport.com/methodology