# K082237: Puritan Bennett, Sandman Duo and Sandman Duo ST

- Pathway: 510(k) (Special)
- Applicant: Mallinckrodt Developpement France
- Decided: Oct 9, 2008 after 63 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: 7 generations back to K903764 (1990). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071575: Sandman Intro, Mallinckrodt Developpement France (2007) Summary page 1.
- K080439: Sandman Info Without Humidifier/ Sandman Auto Without Humidifier, Model M-114801-114802-US; Sandman Info with Intergrate, Mallinckrodt Developpement France (2008) Summary page 1.
- K041819: Goodknight 425, Modelm-114500-00, Mallinckrodt Developpement France (2004) Summary page 1.
- K050072: Goodknight 425ST, Nellcor Puritan Bennett, Inc. (2005) Summary page 1.

## Indications for use
The Sandman Duo and Sandman Duo ST 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/K082237
Methodology: https://510kreport.com/methodology