# K112167: Soyala Silkgel Full Face Mask

- Pathway: 510(k) (Special)
- Applicant: Weinmann Gerate Fur Medizin GmbH + Co. KG
- Decided: Nov 16, 2011 after 111 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 K833786 (1983). 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)
- K073673: Soyala Full Face Mask Gel Vented, Weinmann Gerate Fur Medizin GmbH + Co. KG (2008) Summary page 1.

## Indications for use
The SOYALA SilkGel Full Face Mask is intended for adult patients (>66 pounds or 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/K112167
Methodology: https://510kreport.com/methodology