VPOD ITPR
by Advanced Circulatory System, A Wholly Owned Subsidiary OF
510(k) K172388
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK172388 | Date22 Dec 2017 | 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- Withdrawn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 VPOD ITPR is a Spirometer, Therapeutic (Incentive), designed to regulate intrathoracic pressure during mechanical ventilation. It assists in managing respiratory mechanics by providing controlled resistance to airflow, aiding in lung recruitment and ventilation optimization in critical care settings. The device is intended for use in conjunction with mechanical ventilators to enhance patient outcomes during anesthesia and postoperative care.
The VPOD ITPR is supplied as a reusable medical device and is classified under FDA regulation 868.5690 as a Class II device. It is intended for use in anesthesiology environments and requires proper sterilization and maintenance per manufacturer guidelines. The device is authorized under FDA 510(k) clearance (K172388) and is intended for single-patient use per session, with reprocessing instructions provided by the manufacturer. Compliance with FDA Substantially Equivalent (SESE) standards ensures its safety and performance in clinical applications.
Questions
AI-generated answers, 1 Oct 2026
What is the VPOD ITPR used for in clinical settings?
The VPOD ITPR is an incentive spirometer designed to regulate intrathoracic pressure during mechanical ventilation. It provides controlled resistance to airflow, helping to improve respiratory mechanics, enhance lung recruitment, and optimize ventilation in patients undergoing anesthesia or postoperative care. This aids in maintaining lung function and improving patient outcomes in critical care environments.
Is the VPOD ITPR a single-use or reusable device?
The VPOD ITPR is a reusable medical device. While it is intended for single-patient use per session, it can be reprocessed and reused for subsequent patients following the manufacturer’s sterilization and maintenance guidelines. Proper reprocessing ensures compliance with safety and performance standards.
How should the VPOD ITPR be sterilized and maintained?
The VPOD ITPR requires proper sterilization and maintenance as outlined by the manufacturer’s instructions. Since it is a reusable device, adherence to these guidelines is critical to prevent contamination and ensure safe, effective use across multiple patients. The manufacturer provides detailed reprocessing protocols to maintain device integrity and performance.
What regulatory approval does the VPOD ITPR hold?
The VPOD ITPR holds FDA 510(k) clearance under the classification of a Class II device (FDA regulation 868.5690). It is authorized for use in anesthesiology environments and is considered substantially equivalent (SESE) to a predicate device, ensuring its safety and performance meet regulatory standards.
Are there different models or sizes available for the VPOD ITPR?
The VPOD ITPR is associated with multiple registration numbers, indicating potential variations or configurations, but the core functionality remains consistent across these listings. For specific model or size details, refer to the manufacturer’s documentation or contact Advanced Circulatory Systems directly, as these variations may relate to technical specifications or accessories rather than fundamental device design.