# K142149: Oxytote Infinity Series Vipr Systems

- Pathway: 510(k) (Traditional)
- Applicant: Western/Scott Fetzer Co.
- Decided: Apr 17, 2015 after 255 days
- Product code: ECX (Cylinder, Compressed Gas, And Valve)
- Device class: 1
- Regulation: 21 CFR 868.2700
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K033897 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131386: EZ-OX Plus Generation II, Air Liquide Healthcare America (2014) Summary page 4.

## Recalls of this device
- Aug 15, 2019 · Class II · Z-0343-2020: Limited access to flow settings as a result of the control knob having been rotated beyond its functional range
- Aug 15, 2019 · Class II · Z-0339-2020: Limited access to flow settings as a result of the control knob having been rotated beyond its functional range
- Aug 15, 2019 · Class II · Z-0340-2020: Limited access to flow settings as a result of the control knob having been rotated beyond its functional range
- Aug 15, 2019 · Class II · Z-0341-2020: Limited access to flow settings as a result of the control knob having been rotated beyond its functional range
- Aug 15, 2019 · Class II · Z-0342-2020: Limited access to flow settings as a result of the control knob having been rotated beyond its functional range

## Indications for use
For OxyTOTE Infinity: “The OxyTOTE Infinity system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla and cannot be used directly in the MRI bore. The device is intended for limited duration use, such as would be necessary during patient transports.” For Praxair Grab ‘n Go Opti: “The Grab ‘n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla and cannot be used directly in the MRI bore. The device is intended for limited duration use, such as would be necessary during patient transports.”

Source page: https://510kreport.com/device/K142149
Methodology: https://510kreport.com/methodology