ResQPOD Circulatory Enhancer
by Cprx, LLC
510(k) K022906
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK022906 | Date11 Jun 2003 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- BWF
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5690
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The ResQPOD Circulatory Enhancer is a patient-powered pump designed to enhance blood circulation. It operates by utilizing the patient’s own negative intrathoracic pressures to generate a vacuum in the chest cavity, thereby facilitating improved heart preload and increased blood volume. This device falls under the classification of a therapeutic incentive device and is intended for temporary circulatory support.
The device is intended for use in both home and hospital settings, operated by the patient under physician or licensed practitioner prescription. It is a single-use or reusable device (as per regulatory submission), with no explicit MRI safety restrictions noted in the data. The ResQPOD Circulatory Enhancer holds an FDA 510(k) clearance (K022906) under the Abbreviated pathway, classified as a Class II device (BWF product code). No additional sterility or storage specifications are provided in the regulatory records.
Questions
AI-generated answers, 1 Oct 2026
What is the ResQPOD Circulatory Enhancer designed to do?
The ResQPOD Circulatory Enhancer is a therapeutic incentive device that enhances blood circulation by leveraging the patient’s own negative intrathoracic pressures. It creates a vacuum in the chest cavity, which improves heart preload and increases blood volume, providing temporary circulatory support. This is particularly useful in situations where additional circulatory assistance is needed, such as during recovery or in cases of compromised circulation.
Where can the ResQPOD Circulatory Enhancer be used?
This device is intended for use in both home and hospital settings. It is designed to be operated by the patient under the prescription of a physician or licensed practitioner, making it versatile for various clinical environments where temporary circulatory support is required.
Is the ResQPOD Circulatory Enhancer single-use or reusable?
The ResQPOD Circulatory Enhancer can be used either as a single-use or reusable device, depending on the clinical setting and regulatory submission guidelines. The manufacturer’s instructions should be followed to ensure proper use and maintenance, particularly if reusing the device.
Are there any specific storage requirements for the ResQPOD Circulatory Enhancer?
The regulatory records do not provide explicit sterility or storage specifications for the ResQPOD Circulatory Enhancer. However, standard medical device storage practices should be followed to maintain its functionality and hygiene, especially if the device is reusable. Always refer to the manufacturer’s guidelines for detailed storage instructions.
Does the ResQPOD Circulatory Enhancer have any MRI safety restrictions?
The regulatory data for the ResQPOD Circulatory Enhancer does not explicitly mention MRI safety restrictions. If MRI compatibility is a concern, it is advisable to consult the manufacturer’s documentation or contact their technical support for guidance on safe usage in an MRI environment.