# K042294: Slumbergear (TM), Model Multiple (004, 005, 005, 007)

- Pathway: 510(k) (Traditional)
- Applicant: Suiter Enterprises, Inc.
- Decided: Sep 10, 2004 after 17 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: 4 generations back to K953930 (1996). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021861: Remstar Pro with C-Flex Cpap System, Respironics, Inc. (2002) Summary page 1.
- K031047: Mirage Vista Mask, Resmed, Ltd. (2003) Summary page 1.

## Most influential descendants
- K100343: Pap-Cap (2010), 0 descendants of its own

## Indications for use
SLUMBERGEARTM headgear is an accessory to a non-continuous ventilator (respirator), intended for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinic, and/or home environments. The headgear is reusable and for single-patient use.

Source page: https://510kreport.com/device/K042294
Methodology: https://510kreport.com/methodology