# K073694: Ivent 2001 Mri Conditional

- Pathway: 510(k) (Traditional)
- Applicant: Versamed Medical Systems, Inc.
- Decided: May 30, 2008 after 151 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K902859 (1991). 58 ancestors in all.
6 later devices descend from it; 3 cite it directly.
7 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061627: Modification to I Vent 201, Versamed Medical Systems, Inc. (2006) Summary page 1.
- K063404: Servo-I Ventilator System, Models 64, 87 and 800, Maquet Critical Care AB (2007) Summary page 1.

## Most influential descendants
- K090888: Newport HT70 Family of Ventilators (2009), 2 descendants of its own
- K083688: Pulmonetic Systems LTV 1200 MR Conditional Ventilator (2009), 2 descendants of its own
- K111146: Newport HT70 Ventilator (2011), 1 descendant of its own
- K240807: VM-2000 (2024), 0 descendants of its own
- K202970: Ventway Sparrow (2021), 0 descendants of its own

## Indications for use
The iVent TM 201 MR Conditional is a portable, computer controlled, electrically powered intensive care ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for use with adult through pediatric patients, who require invasive or non-invasive assistance via the following general modes of ventilatory support, as prescribed by an attending physician: Assist/Control (Pressure Controlled or Volume Controlled) SIMV (Pressure Controlled or Volume Controlled) CPAP/PSV The iVentTM 201 MR Conditional ventilator is suitable for use in the ICU and all other hospital areas, including Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field, in all hospital-type facilities, alternate care sites, transport, emergency and in the home environment. The iVentT M 201 MR Conditional ventilator is MR Conditional. The optional non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate and is suitable for use in all above mentioned areas, excluding MR environments. The iVentTM 201 MR Conditional ventilator is a restricted medical device intended for use by qualified, trained personnel under the direct supervision of a physician.

Source page: https://510kreport.com/device/K073694
Methodology: https://510kreport.com/methodology