# K021981: Ivent 201 Portable Ventilator

- Pathway: 510(k) (Abbreviated)
- Applicant: Versamed, Ltd.
- Decided: Aug 13, 2003 after 422 days
- Product code: NOU (Continuous, Ventilator, Home 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: 3 generations back to K962603 (1997). 3 ancestors in all.
125 later devices descend from it; 4 cite it directly.
42 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990966: Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor, Masimo Lnop -PDT-Pediatric/Small Dis, Masimo Corp. (1999) Summary page 5.

## Most influential descendants
- K042468: Ivent 201 Portable Ventilator (2004), 123 descendants of its own
- K052554: Modification to: Ivent 201 Portable Ventilator (2005), 112 descendants of its own
- K053270: IVENT 201 (2006), 87 descendants of its own
- 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

## 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 Ib.), who require the following general modes of ventilatory support, as prescribed by an attending physician: * Assist/Control (Pressure Controlled or Volume Controlled) e SIMV (Pressure Controlled or Volume Controlled) * CPAP/PSV The iVent™ 201 ventilator with Non-Invasive Portable Oximeter is suitable for intra-hospital use, home and alternate-site use, transport and energy 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/K021981
Methodology: https://510kreport.com/methodology