Soyala Gel Vented

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K081014 ↗

FDA Product Code

BZD

Device Class

Class II

Regulation

21 CFR Part 868.5905

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• NP15

  Class II

  FDA 510(k) K102515 Active Cleared 11 Mar 2011

• Easyfit Silkgel Nasal Mask

  Class II

  FDA 510(k) K110884 Active Cleared 12 Jul 2011

• Soyala, Soyala Blue

  Class II

  FDA 510(k) K060405 Active Cleared 21 Jun 2006

• Soyala Full Face Mask Gel Vented

  Class II

  FDA 510(k) K073673 Active Cleared 28 Mar 2008

• Soyala Full Face Mask

  Class II

  FDA 510(k) K061653 Active Cleared 9 Nov 2006

• Weinmanncompact, Model Wm 27380; WEINMANNCLICK2, Model Wm 27340

  Class II

  FDA 510(k) K072009 Active Cleared 14 Dec 2007

See all devices from Weinmann Gerate Fur Medizin GmbH + Co. KG →

• What types of patients is the Soyalagel Vented nasal mask designed for, and what weight requirement must be met?

  The Soyalagel Vented nasal mask is specifically designed for adult patients who weigh over 30 kg. It is intended for use during nasal ventilation procedures, such as continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BiPAP) therapy in clinical settings like hospitals or home care.

• Is the Soyalagel Vented nasal mask reusable or single-use, and what are the storage requirements?

  The Soyalagel Vented nasal mask is supplied as a single-use device. It is non-sterile and must be stored in a clean, dry environment until use. This ensures optimal conditions for maintaining its integrity and functionality before clinical application.

• What regulatory pathway was followed for the approval of the Soyalagel Vented nasal mask, and which medical specialty is associated with its use?

  The Soyalagel Vented nasal mask was authorized through an FDA 510(k) clearance process, specifically under clearance number K081014. It is classified under the medical specialty of Anesthesiology, reflecting its intended use in ventilatory support procedures.

• Can the Soyalagel Vented nasal mask be used in an MRI environment, and why?

  No, the Soyalagel Vented nasal mask is not MRI-safe. This means it should not be used in or near MRI machines, as the magnetic fields could potentially damage the device or pose risks to the patient.

• What is the primary material of the Soyalagel Vented nasal mask, and how does this affect its usability?

  The Soyalagel Vented nasal mask is made of molded plastic, which makes it lightweight and suitable for single-use applications. Since it is non-sterile, it is intended for use in clinical settings where sterility can be ensured through proper handling and preparation procedures.