# K101401: Neumovent Graphnet Model 3179L1V

- Pathway: 510(k) (Traditional)
- Applicant: Tecme S.A.
- Decided: Dec 7, 2010 after 203 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Neumovent GraphNet is intended to provide continuous ventilation to patients requiring respiratory support. The device is intended for patients from neonate/infant to adult and for a wide variety of clinical conditions. The device is intended to be used in hospital and hospital-type facilities and during hospital and hospital-type transport provided that electrical power and compressed gas are supplied.

Source page: https://510kreport.com/device/K101401
Methodology: https://510kreport.com/methodology