BiWaze Clear System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Abmrc LLC
Identity
- Trade Name
- BiWaze Clear System EUDAMED
- Device Name
- BiWaze Clear System EUDAMED
- Model / Reference
- BK940, BK939 EUDAMEDBK939, BK940 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B965BK9390 EUDAMED
- Basic UDI-DI
- ++B965BK940VX EUDAMED
- 510(k) Number
- K231728 FDA 510(k)
- FDA Product Code
- NHJ FDA 510(k)
- EMDN Code
- R05010302 DOUBLE-CHAMBER MUCOUS MEMBRANE ASPIRATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5905 FDA 510(k)
- Regulation Number
- 868.5905 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
Yes
Measuring Function
No
Incorporates Medicinal Product
No
The BiWaze Clear System is a Positive Pressure Breathing, Intermittent device designed for use in anesthesia. It delivers controlled ventilation to patients during surgical procedures, ensuring adequate oxygenation and ventilation while minimizing airway trauma.
This system is supplied as a reusable medical device and is intended for use in operating rooms and anesthesia care settings. It is classified as a Class II device under FDA regulations and has received FDA 510(k) clearance. The device is regulated under the regulation number 868.5905 and is intended for single-patient use per procedure.
Frequently asked questions
Is the BiWaze Clear System designed for single-use or reusable applications in the operating room?
The BiWaze Clear System is explicitly designed as a reusable medical device for use in anesthesia during surgical procedures. While it is intended for single-patient use per procedure, it is not disposable and can be cleaned, disinfected, and reused for subsequent procedures, provided proper maintenance protocols are followed.
What types of surgical settings or specialties is this device intended for?
The BiWaze Clear System is specifically designed for anesthesia care settings, including operating rooms where controlled ventilation is required during surgical procedures. Its regulatory classification and advisory committee designation (Anesthesiology) confirm its primary use in this clinical context.
How is the BiWaze Clear System regulated, and what does that mean for its use?
The BiWaze Clear System is classified as a Class II device under FDA regulations and has received 510(k) clearance, meaning it has been determined to be substantially equivalent to a legally marketed device. This classification ensures it meets FDA safety and effectiveness standards for positive pressure breathing devices in anesthesia, though it does not imply any specific clinical indication beyond its intended use.
Are there multiple models or sizes available for the BiWaze Clear System, and how would I identify them?
The BiWaze Clear System is associated with multiple registration numbers (e.g., 3011120183, 3042507287, etc.) in the FDA registry, which may correspond to different configurations or variants. However, the manufacturer does not specify distinct sizes or models in the provided data. For precise details on available models, contact Abmrc LLC at 860 Blue Gentian Rd., Suite 200, Eagan, MN 55121 or reach out to their contact, Leah Noaeill.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K231728 | Class II | Active |
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Manufacturer
- Manufacturer
- Abmrc LLC
- FDA Applicant
- Abmrc, LLC
Sources (3)
- FDA 510(k) K231728 24 fields · synced Sep 18, 2026
- EUDAMED 9d73e264-23b9-4454-9e8d-2f2043d77fd6-1 61 fields · synced Jul 9, 2026
- EUDAMED 9d73e264-23b9-4454-9e8d-2f2043d77fd6-2 61 fields · synced Jul 9, 2026