# K013738: Weinmann Somnomask

- Pathway: 510(k) (Traditional)
- Applicant: Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits
- Decided: Jan 22, 2002 after 70 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: 3 generations back to K833786 (1983). 5 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991648: Reusable Contour II Nasal Mask, Respironics, Inc. (1999) Summary page 1.
- K002001: Breeze Sleepgear with Dreamseal, Puritan Bennett Corp. (2000) Summary page 1.

## Most influential descendants
- K061653: Soyala Full Face Mask (2006), 2 descendants of its own
- 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 Weinmann SOMNOmask 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/K013738
Methodology: https://510kreport.com/methodology