510(k) · Cleared
Recalled · Class II · 2019Oxytote Infinity Series Vipr Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Western/Scott Fetzer Co. · ECX Cylinder, Compressed Gas, And Valve
Cleared on Apr 17, 2015 as substantially equivalent to K131386 (Air Liquide Healthcare America, 2014) after a 255-day review. Its family tree reaches back 3 generations to 2004. It has been recalled 5 times.
- Decided
- Apr 17, 2015
- Review
- 255 days
- Class
- Class I
- Product code
- ECX
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 3 generations to K033897 (2004). No later device cites it as a predicate yet.
- Root · 3 generations backK033897 Medicyl-E-Lite Portable Oxygen Delivery SystemAga-Linde Health Care · 2004
- 2 generations backK053117 EZ-OX PlusAir Liquide Healthcare America · 2006
- 1 generation backK131386 EZ-OX Plus Generation IIAir Liquide Healthcare America · 2014
- This deviceK142149 Oxytote Infinity Series Vipr SystemsWestern/Scott Fetzer Co. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K033897 | Medicyl-E-Lite Portable Oxygen Delivery System | Aga-Linde Health Care | 2004 | — |
| −2 | K053117 | EZ-OX Plus | Air Liquide Healthcare America | 2006 | — |
| −1 | K131386 | EZ-OX Plus Generation II | Air Liquide Healthcare America | 2014 | — |
| 0 (this device) | K142149 | Oxytote Infinity Series Vipr Systems | Western/Scott Fetzer Co. | 2015 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ECX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K131386 | EZ-OX Plus Generation IISummary page 4…e The predicate device for the OxyTOTE Infinity and Praxair Grab ‘n Go Opti series VIPR Systems is the EZ- OX Plus Generation II, which was cleared under 510(k) K131386. Western would like to advise that they were also the manufacturer of this device. Volume Number 2… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 15, 2019 | Class II | Z-0343-2020 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | Limited access to flow settings as a result of the control knob having been rotated beyond its functional range |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All ECX devicesECX Cylinder, Compressed Gas, And Valve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · ECX
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · ECX
Too few ECX 510(k)s in any year since 2007 to give a median.
Recalls per year · ECX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ECX
1in 2025
MAUDE reports naming product code ECX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 4 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 0 | — | 9 | 3 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 1 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 6 |
| 2015 | 2 | — | 0 | 6 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 5 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 1 | 4 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
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…
Read the full statement (193 words)
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.”
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142149 · printed Nov 3, 2026
Cite this page
510(k) Report. “K142149: Oxytote Infinity Series Vipr Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K142149
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026