# K080439: Sandman Info Without Humidifier/ Sandman Auto Without Humidifier, Model M-114801-114802-US; Sandman Info with Intergrate

- Pathway: 510(k) (Special)
- Applicant: Mallinckrodt Developpement France
- Decided: May 16, 2008 after 87 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). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 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 3.
- K042184: Goodknight H20, Model M-114600-00, Mallinckrodt Developpement France (2005) Summary page 3.

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

## Indications for use
The Sandman Info, and Sandman Auto are indicated for the treatment of obstructive sleep apnea in spontaneously breathing patients weighing more than 30kg (661b) within homecare and hospital environments.

Source page: https://510kreport.com/device/K080439
Methodology: https://510kreport.com/methodology