# K061653: Soyala Full Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Weinmann Gerate Fur Medizin GmbH + Co. KG
- Decided: Nov 9, 2006 after 149 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 K833786 (1983). 14 ancestors in all.
2 later devices descend 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)
- K023244: Mirage Full Face Mask Series 2, Resmed, Ltd. (2002) Summary page 1.
- K013738: Weinmann Somnomask, Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits (2002) Summary page 1.
- K060405: Soyala, Soyala Blue, Weinmann Gerate Fur Medizin GmbH + Co. KG (2006). Cleared while this submission was under review Summary page 1.
- K040506: Flexifil Series HC431 Full Face Mask, Model HC431A, Fisher & Paykel Healthcare, Ltd. (2004) Summary page 1.

## Most influential descendants
- K073673: Soyala Full Face Mask Gel Vented (2008), 1 descendant of its own
- K112167: Soyala Silkgel Full Face Mask (2011), 0 descendants of its own

## Indications for use
The SOYALA 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/K061653
Methodology: https://510kreport.com/methodology