# K081845: IVENT101

- Pathway: 510(k) (Traditional)
- Applicant: Versamed Medical Systems, Inc.
- Decided: Mar 16, 2009 after 259 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: 9 generations back to K902859 (1991). 66 ancestors in all.
No later device cites it as a predicate yet.
5 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060647: LTV 1200 Ventilator, Pulmonetic Systems, Inc. (2006) Summary page 3.
- K061627: Modification to I Vent 201, Versamed Medical Systems, Inc. (2006) Summary page 3.
- K034032: PLV Continuum Ventilator, Model P2000, Respironics California, Inc. (2004) Summary page 3.
- K070899: Puritan Bennett Legendair XL2, Nellcor Puritan Bennett (2007) Summary page 3.

## 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. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. 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 Adaptive Bi-Level for either NIV or invasive ventilation. The iVentI 01 ventilator is suitable for use in institution, home and portable settings.

Source page: https://510kreport.com/device/K081845
Methodology: https://510kreport.com/methodology