# K053270: IVENT 201

- Pathway: 510(k) (Special)
- Applicant: Versamed Medical Systems, Inc.
- Decided: Jan 27, 2006 after 65 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: 7 generations back to K902859 (1991). 40 ancestors in all.
87 later devices descend from it; 3 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)
- K052554: Modification to: Ivent 201 Portable Ventilator, Versamed Medical Systems, Inc. (2005) Summary page 2.
- K032451: Bird Tbird Vela Ventilator, Bird Products Corp. (2004) Summary page 2.

## Most influential descendants
- K061627: Modification to I Vent 201 (2006), 86 descendants of its own
- 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

## Indications for use
The iVent 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lb.), 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 iVent 201 ventilator with Non-invasive Pulse Oximeter is suitable for intra-hospital use, home and alternate-site use, transport and emergency use. The Non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate. The iVent 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the technical specification limits.

Source page: https://510kreport.com/device/K053270
Methodology: https://510kreport.com/methodology