# K072926: Helontix Vent

- Pathway: 510(k) (Traditional)
- Applicant: Linde Gas Therapeutics
- Decided: Oct 15, 2008 after 366 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: 7 generations back to K902859 (1991). 36 ancestors in all.
No later device cites it as a predicate yet.
4 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970460: Nellcor Puritan Bennett, 840 Ventilator System (Model 840), Puritan Bennett Corp. (1998) Summary page 1.
- K041524: GE Datex-Ohmeda Heliox Delivery System, Datex-Ohmeda, Inc. (2004) Summary page 1.
- K041223: Modification to Servo-I Ventilator System, Model 64 87 800 E407E, Maquet Critical Care AB (2004) Summary page 1.

## Indications for use
The Helontix Vent is designed to deliver helium/oxygen mixtures to spontaneously breathing patients via a facemask with or without pressure support. The system is designed for facility use and should only be used under the orders of a clinician. The Helontix Vent delivery system is not intended as a life support device and is not intended for intubated patients.

Source page: https://510kreport.com/device/K072926
Methodology: https://510kreport.com/methodology