# K061627: Modification to I Vent 201

- Pathway: 510(k) (Special)
- Applicant: Versamed Medical Systems, Inc.
- Decided: Jun 29, 2006 after 17 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: 8 generations back to K902859 (1991). 41 ancestors in all.
86 later devices descend from it; 7 cite it directly.
35 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053270: IVENT 201, Versamed Medical Systems, Inc. (2006) Summary page 2.

## Most influential descendants
- K063404: Servo-I Ventilator System, Models 64, 87 and 800 (2007), 61 descendants of its own
- K081842: Engstrom Carestation, Engstrom Pro (2008), 37 descendants of its own
- K073179: Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585 (2008), 28 descendants of its own
- K093886: Engstrom Carestation, Engstrom Pro (2010), 21 descendants of its own
- K103803: Hamilton-G5 (2011), 14 descendants of its own

## Indications for use
The iVentrF t 201 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 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 iVelzdLM 201 ventilator (with or without the non-invasive Pulse Oximeter option) is suitable for use in the ICU and all other hospital areas. in all hospital-type facilities. alternate-care sites, transport, emergency and in the home environment. The 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. The i VentIt 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician

Source page: https://510kreport.com/device/K061627
Methodology: https://510kreport.com/methodology