Identifiers
- 510(k) Number
- K833748 FDA 510(k)
- FDA Product Code
- CBP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5870 FDA 510(k)
- Regulation Number
- 868.5870 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Rescue Valve is a Non-Rebreathing Valve (product code CBP), designed to prevent backflow of gases or fluids from the patient circuit into respiratory support systems. It functions as a one-way mechanism to maintain unidirectional airflow, ensuring patient safety during use with BiPAP or CPAP devices.
Supplied as a single-use device, the Rescue Valve is intended for use in anesthesia and respiratory care settings. It is spring-loaded and does not require sterilization or reprocessing. The device is classified under FDA 510(k) clearance (K833748) and falls under Class II regulatory controls, with no specific MRI safety considerations noted. Storage should follow manufacturer guidelines to preserve functionality.
Frequently asked questions
What is the primary purpose of the Rescue Valve in respiratory care settings?
The Rescue Valve is designed as a non-rebreathing valve to prevent backflow of gases or fluids from the patient circuit into respiratory support systems. This ensures unidirectional airflow, which is critical for maintaining patient safety during use with BiPAP or CPAP devices in anesthesia and respiratory care environments.
Is the Rescue Valve intended for reuse or is it a single-use device?
The Rescue Valve is explicitly supplied as a single-use device, meaning it is not meant to be reprocessed or reused after one use. This design eliminates the need for sterilization or cleaning, simplifying its use in clinical settings.
How should the Rescue Valve be stored to ensure it remains functional?
The Rescue Valve should be stored according to the manufacturer’s guidelines to preserve its functionality. While specific storage instructions aren’t detailed in the data, adhering to the manufacturer’s recommendations—likely involving protection from contamination, extreme temperatures, or physical damage—will ensure proper performance.
What regulatory pathway was followed for FDA clearance of the Rescue Valve?
The Rescue Valve received FDA clearance through a 510(k) submission (K833748) under the Traditional clearance type, with a Substantially Equivalent determination. It falls under Class II regulatory controls and is categorized under the Anesthesiology advisory committee (AN), reflecting its use in anesthesia and respiratory care settings.
Are there any special considerations for using the Rescue Valve in MRI environments?
The Rescue Valve does not have any specific MRI safety considerations noted in the provided data, meaning it is not explicitly labeled as MRI-safe or unsafe. However, clinicians should always verify compatibility with their MRI facility’s protocols, as non-metallic or non-ferromagnetic components are critical for safe use in such environments.
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. Sources consulted: RESCUE VALVE (K833748) - FDA 510 (k), PDF 1066903_ML - Philips, Philips Respironics Backflow Valve | The CPAP Shop, Respironics CPAP Pressure Valve - East Coast Medical Supply
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K833748 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Respironics, Inc.
Sources (1)
- FDA 510(k) K833748 24 fields · synced Sep 19, 2026