Mercury Medical PEEP Valve

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

No FDA recalls on record, checked 22 Oct 2026.

Trade Name

PEEP Valve

Generic Name

PEEP valve, single-use

Device Name

Positive End Expiratory Pressure (PEEP) VAlve

Model / Reference

10-55330, 10-55310

Primary DI / UDI-DI

10641043553305

Basic UDI-DI

0641043PENC

510(k) Number

K081266 ↗

FDA Product Code

BYE

EMDN Code

R028001 Respiratory circuits valves

GMDN Term

PEEP valve, single-use

Device Class

Class I EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 868.5965

Market of Registration

Netherlands

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

Commercial Distribution

In Commercial Distribution

MRI Safety

MR Conditional

• What clinical setting is the Mercury Medical PEEP Valve primarily intended for, and how does it function in that environment?

  The Mercury Medical PEEP Valve is designed for use in critical care settings, specifically during mechanical ventilation. It functions as a single-use attachment to regulate and maintain positive end-expiratory pressure (PEEP) in a patient’s airway. By providing controlled exhalation resistance, it helps prevent alveolar collapse, thereby supporting stable respiratory function in patients requiring assisted ventilation.

• Is the Mercury Medical PEEP Valve reusable, or is it intended for single-use only? What does this mean for clinical workflow?

  The Mercury Medical PEEP Valve is explicitly intended for single-use only and does not require additional sterilization or reprocessing before use. This design ensures patient safety by eliminating the risk of cross-contamination between patients, simplifying clinical workflows as there’s no need for cleaning or reprocessing—just replace and use.

• What regulatory pathways has the Mercury Medical PEEP Valve followed, and what does this mean for its compliance and use?

  The device has undergone regulatory review through FDA 510K clearance and MDR (Medical Device Regulation) in the EU, adhering to Class II standards. It was determined *substantially equivalent* to a predicate device, with its primary advisory committee being Anesthesiology (AN). This means it meets strict safety and performance requirements for use in mechanical ventilation systems, ensuring compliance with both U.S. and EU regulatory frameworks.

• Are there multiple sizes or models of the Mercury Medical PEEP Valve, or is it available in a single configuration?

  The device is available in multiple configurations, as indicated by the extensive list of FEI numbers (e.g., 3013557562, 3006061749, etc.) and registration numbers in the data. While the exact specifications (e.g., pressure settings, connector types) aren’t detailed here, these identifiers suggest variations may exist to accommodate different ventilator systems or patient needs. Contacting Mercury Medical directly would provide clarity on specific sizing or model options.

• How should the Mercury Medical PEEP Valve be stored to maintain its sterility and functionality?

  Since the device is sterile for single-use, it should be stored in its original, sealed packaging until immediately before use. The packaging must remain intact to preserve sterility. Storage conditions should follow manufacturer guidelines (typically room temperature, protected from moisture/direct sunlight), as improper storage could compromise the valve’s integrity or performance. Always check the packaging for expiration dates or tamper-evidence before use.