# K041524: GE Datex-Ohmeda Heliox Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Sep 20, 2004 after 104 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: 6 generations back to K902859 (1991). 23 ancestors in all.
30 later devices descend from it; 2 cite it directly.
15 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022674: Bird Avea Ventilator, Bird Products Corp. (2002) Summary page 3.
- K922705: Model  7200AE Ventilator, Puritan Bennett Corp. (1994) Summary page 3.

## Most influential descendants
- K073179: Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585 (2008), 28 descendants of its own
- K131774: Hamilton-G5 (2013), 10 descendants of its own
- K123149: Servo-I Ventilator System (2014), 9 descendants of its own
- K083693: PB 840 Ventilator System  with Leak Compensation Option, Model 840 (2009), 6 descendants of its own
- K103211: Avea Ventilator (2011), 5 descendants of its own

## Indications for use
The GE Datex-Ohmeda Apta6r Heliox delivery system is designed to deliver heliox from a source gas cylinder to spontaneously breathing patients via a sealed facemask using pressure support. A built-in nebulizer, the Aerogen Aeroneb Pro (K021175) is provided for adding nebulized medication to the delivered heliox. The system is designed for facility use and should only be used under the orders of a clinician. The Apta6r Heliox Delivery System is not intended as a life support device and is not intended for intubated patients.

Source page: https://510kreport.com/device/K041524
Methodology: https://510kreport.com/methodology