510(k) · Cleared
ClearedEZ-OX Plus Generation II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Air Liquide Healthcare America · ECX Cylinder, Compressed Gas, And Valve
Cleared on Mar 14, 2014 as substantially equivalent to K053117 (Air Liquide Healthcare America, 2006) after a 304-day review. Its family tree reaches back 2 generations to 2004. 1 later device descends from it.
- Decided
- Mar 14, 2014
- Review
- 304 days
- Class
- Class I
- Product code
- ECX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K033897 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK033897 Medicyl-E-Lite Portable Oxygen Delivery SystemAga-Linde Health Care · 2004
- 1 generation backK053117 EZ-OX PlusAir Liquide Healthcare America · 2006
- This deviceK131386 EZ-OX Plus Generation IIAir Liquide Healthcare America · 2014
- Descendant · cites it directly · 0 of its ownK142149 Oxytote Infinity Series Vipr SystemsWestern/Scott Fetzer Co. · 2015 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K142149Oxytote Infinity Series Vipr SystemsWestern/Scott Fetzer Co. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K033897 | Medicyl-E-Lite Portable Oxygen Delivery System | Aga-Linde Health Care | 2004 | — |
| −1 | K053117 | EZ-OX Plus | Air Liquide Healthcare America | 2006 | — |
| 0 (this device) | K131386 | EZ-OX Plus Generation II | Air Liquide Healthcare America | 2014 | — |
| +1 | K142149 | Oxytote Infinity Series Vipr Systems | Western/Scott Fetzer Co. | 2015 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
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 |
|---|---|---|---|
| * | K053117 | EZ-OX PlusSummary page 2…bove mentioned assembly. 5. PREDICATE DEVICE(s) The predicate device for the EZ-OX Plus Generation H is the EZ-OX Plus, which was approved under 510(k) K0531 17. 6. DEVICE DESCRIPTION The EZ-OX Plus Generation HI portable oxygen system is a solution for supplying Oxygen USP u… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142149 | Oxytote Infinity Series Vipr Systems | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 7.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K142149 (Western/Scott Fetzer Co., 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K053117.
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. 2014, 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?
The EZ-OX Plus Generation Illis an integrated portable oxygen delivery system intended to provide supplemental oxygen to patients. When administered by propeuly trained personnel for oxygen deficiency and resuscitation, the EZ-OX Plus Generation IllIs for emergency use only. For all other medical applications, the device Is Rx only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131386 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131386: EZ-OX Plus Generation II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131386
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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