# K112754: IVENT101

- Pathway: 510(k) (Traditional)
- Applicant: Versamed Medical Systems, Ltd.
- Decided: Jun 15, 2012 after 268 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: 6 generations back to K902859 (1991). 33 ancestors in all.
9 later devices descend from it; 1 cites it directly.
6 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092135: Modification to Ivent 101, Versamed Medical Systems, Ltd. (2009) Summary page 1.
- K083526: Trilogy 100 Ventilator, Respironics Inc., Sleep & Home Respiratory Group (2009) Summary page 1.

## Most influential descendants
- K123144: VIVO 50 (2013), 8 descendants of its own
- K160481: Vivo 60 (2016), 7 descendants of its own
- K181166: Trilogy Evo (2019), 5 descendants of its own
- K193586: Vivo 45 LS (2021), 2 descendants of its own
- K232365: Vivo 45 LS (2025), 0 descendants of its own

## Indications for use
The iVent101 ventilator [with single or dual limb configuration] is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for infants from 5 kg through adult patients who require invasive or non-invasive support via the following ventilatory modalities: Assist/Control and SIMV with either Volume, Pressure, or Pressure Regulated Volume Control (PRVC) CPAP with Pressure Support and CPAP / Pressure Support Volume Guaranteed [VG) Adaptive Bi-Level for either NIV or invasive ventilation and Adaptive Bi-Level Volume Guaranteed [VG] The iVent101 ventilator is suitable for use in institution, home and portable settings

Source page: https://510kreport.com/device/K112754
Methodology: https://510kreport.com/methodology