# K201082: LTV2 Series Ventilators

- Pathway: 510(k) (Traditional)
- Applicant: Vyaire Medical, Inc.
- Decided: Nov 10, 2021 after 566 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). 52 ancestors in all.
No later device cites it as a predicate yet.
5 of 53 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 4.
- K101643: Model LTV 1100 Ventilator, Care Fusion (2011) Summary page 4.

## Indications for use
LTV2 model 2200 and 2150 ventilators are intended to provide continuous or intermittent ventilator support for the care of the individuals who require mechanical ventilation. The use environment is for institutional use. Institutional use includes ICU or other hospital environments including intra-hospital transport. The model 2200 can operate with high pressure O2. The model 2150 operates with low pressure oxygen.

Source page: https://510kreport.com/device/K201082
Methodology: https://510kreport.com/methodology