# K240807: VM-2000

- Pathway: 510(k) (Traditional)
- Applicant: Ventis Medical, Inc.
- Decided: Aug 13, 2024 after 141 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: 13 generations back to K953930 (1996). 188 ancestors in all.
No later device cites it as a predicate yet.
18 of 189 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083688: Pulmonetic Systems LTV 1200 MR Conditional Ventilator, Pulmonetic Systems, Inc. (2009) Summary page 5.
- K181166: Trilogy Evo, Respironics, Inc. (2019) Summary page 5.

## Indications for use
The VM-2000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation in emergency and transport situations. The ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult patients, who require the following types of ventilatory support: - Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasively (via mask). - Assist/Control, SIMV, CPAP and NPPV modes of ventilation. The ventilator is suitable for use in institutional or transport settings.

Source page: https://510kreport.com/device/K240807
Methodology: https://510kreport.com/methodology