# K981668: Smartvent 201 Portable Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Versamed, Ltd.
- Decided: Apr 7, 1999 after 331 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: 1 generation back to K943531 (1995). 2 ancestors in all.
136 later devices descend from it; 4 cite it directly.
45 of 139 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950484: Tbird VS Ventilator and Tbird Avs Ventilator, Bird Products Corp. (1996) Summary page 5.
- K943531: Oxylog 2000, Drager, Inc. (1995) Summary page 5.

## Most influential descendants
- K011957: Ivent 201 Portable Ventilator (2001), 134 descendants of its own
- 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

## Indications for use
The SmartVent™ 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 1b.), 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) e CPAP/PSV The SmartVent™ 201 ventilator is suitable for intra-hospital use, home and alternate-site use, transport and energy use. The SmartVent™ 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/K981668
Methodology: https://510kreport.com/methodology