# K073673: Soyala Full Face Mask Gel Vented

- Pathway: 510(k) (Special)
- Applicant: Weinmann Gerate Fur Medizin GmbH + Co. KG
- Decided: Mar 28, 2008 after 92 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 K833786 (1983). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061653: Soyala Full Face Mask, Weinmann Gerate Fur Medizin GmbH + Co. KG (2006) Summary page 1.

## Most influential descendants
- K112167: Soyala Silkgel Full Face Mask (2011), 0 descendants of its own

## Indications for use
The Full Face Mask is intended for adult patients (>30kg) prescribed continuous positive airway pressure (CPAP) or bi-level therapy for multiple patient use in a hospital or clinic environment after high-level disinfection and for single-patient use in a home environment.

Source page: https://510kreport.com/device/K073673
Methodology: https://510kreport.com/methodology