Ivent 201 Portable Ventilator
510(k) K011957
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK011957 | Date18 Jul 2001 | 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- Withdrawn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
- FDA applicant
- Versamed , Ltd.
- 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 Ivent 201 Portable Ventilator is a continuous, facility-use ventilator designed to provide mechanical ventilation. As classified under the FDA’s device nomenclature, it is a microprocessor-controlled system capable of delivering controlled or assisted ventilation, offering the performance of larger ventilators in a portable form. The device is intended for use in clinical environments requiring respiratory support.
The Ivent 201 is a reusable, turbine-powered ventilator featuring an internal rechargeable battery for portability. It operates in facility-based settings and is regulated under FDA 510(k) clearance (K011957) with a Special 510(k) designation. The device is not MRI-safe and must be stored and maintained according to manufacturer instructions to ensure proper functionality and compliance.
Ivent 201 Portable Ventilator
Other devices from Versamed, Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the Ivent 201 Portable Ventilator designed for?
The Ivent 201 Portable Ventilator is a microprocessor-controlled device intended for facility-based clinical environments requiring mechanical ventilation. It provides controlled or assisted ventilation, replicating the performance of larger ventilators in a portable form. This makes it suitable for settings where respiratory support is needed but space or mobility constraints exist.
Is the Ivent 201 Portable Ventilator reusable or single-use?
The Ivent 201 Portable Ventilator is reusable, designed for repeated use in facility settings. Like all reusable medical devices, it must be cleaned, maintained, and serviced according to the manufacturer’s instructions to ensure proper functionality, sterility, and compliance with regulatory requirements.
How does the portability of the Ivent 201 Portable Ventilator work?
The Ivent 201 achieves portability through a turbine-powered design and an internal rechargeable battery, allowing it to operate outside traditional fixed ventilation setups. This enables clinicians to provide ventilation support in mobile or space-constrained clinical areas while maintaining performance comparable to larger, stationary ventilators.
What storage and maintenance requirements does the Ivent 201 Portable Ventilator have?
The Ivent 201 must be stored and maintained strictly per the manufacturer’s guidelines to preserve functionality and regulatory compliance. This includes proper handling of the rechargeable battery, regular servicing, and adherence to cleaning protocols—especially important for a reusable device in clinical use. Improper storage or maintenance could compromise performance or safety.
Is the Ivent 201 Portable Ventilator MRI-safe?
No, the Ivent 201 Portable Ventilator is not MRI-safe. It should never be used or stored near MRI equipment, as exposure to magnetic fields could damage the device or pose risks to patients. Always verify the environment’s safety before use.