IVENT101
by Versamed Medical Systems, Inc.
510(k) K081845
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK081845 | Date16 Mar 2009 | 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- Withdrawn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
- CBK
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5895
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The IVent101 is a continuous, facility-use ventilator designed to deliver mechanical ventilatory support. Classified as a Class II device under FDA regulation 868.5895, it is intended for use in clinical settings to provide both continuous and intermittent ventilation for patients requiring respiratory assistance. The device supports single or dual limb configurations to accommodate various patient needs and clinical scenarios.
The IVent101 is supplied as a reusable medical device and is intended for use in hospital or facility environments. It has been granted FDA 510(k) clearance under the Traditional 510(k) Review pathway, with a decision date of March 16, 2009. The device is regulated under the Anesthesiology advisory committee and is assigned the product code CBK. No specific sterility or MRI safety information is provided in the regulatory data.
Other devices from Versamed Medical Systems, Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the IVent101 used for in clinical settings?
The IVent101 is a facility-use ventilator designed to provide mechanical ventilatory support for patients requiring respiratory assistance. It delivers both continuous and intermittent ventilation, making it suitable for hospital environments where sustained respiratory care is needed. Its dual-limb configuration allows flexibility to accommodate various patient needs and clinical scenarios.
Is the IVent101 a single-use or reusable device?
The IVent101 is a reusable medical device, intended for use in hospital or facility environments. Unlike single-use devices, it is engineered for repeated use within a clinical setting, ensuring durability and cost-effectiveness for long-term respiratory support.
What types of configurations does the IVent101 support?
The IVent101 supports both single and dual limb configurations, allowing clinicians to adapt the device to different patient requirements. This flexibility ensures compatibility with a range of ventilation scenarios, from basic respiratory support to more complex clinical needs.
Is there any information provided about sterility or MRI safety for the IVent101?
The regulatory data for the IVent101 does not specify details regarding sterility or MRI safety. Clinicians should consult the manufacturer’s instructions for use or additional documentation for guidance on these aspects before implementation.
What regulatory pathway was followed for the IVent101’s clearance?
The IVent101 received FDA 510(k) clearance under the Traditional 510(k) Review pathway, with a decision date of March 16, 2009. It is classified as a Class II device under FDA regulation 868.5895 and falls under the Anesthesiology advisory committee, with the product code CBK.