# K081014: Soyala Gel Vented

- Pathway: 510(k) (Special)
- Applicant: Weinmann Gerate Fur Medizin GmbH + Co. KG
- Decided: May 9, 2008 after 30 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: 1 generation back to K060405 (2006). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060405: Soyala, Soyala Blue, Weinmann Gerate Fur Medizin GmbH + Co. KG (2006) Summary page 1.

## Most influential descendants
- K110884: Easyfit Silkgel Nasal Mask (2011), 0 descendants of its own

## Indications for use
The nasal mask is intended for prescription use to be used during nasal CPAP or Bi-level Positive Pressure therapy for adult patients (>30 kg).

Source page: https://510kreport.com/device/K081014
Methodology: https://510kreport.com/methodology