510(k) · Cleared
ClearedEZ-OX Plus
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 Apr 10, 2006 as substantially equivalent to K033897 (Aga-Linde Health Care, 2004) after a 154-day review. Its family tree reaches back 1 generation to 2004. 5 later devices descend from it.
- Decided
- Apr 10, 2006
- Review
- 154 days
- Class
- Class I
- Product code
- ECX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K033897 (2004). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK033897 Medicyl-E-Lite Portable Oxygen Delivery SystemAga-Linde Health Care · 2004
- This deviceK053117 EZ-OX PlusAir Liquide Healthcare America · 2006
- Descendant · cites it directly · 1 of its ownK143060 Intelli-OxAir Liquide Healthcare · 2015
- Descendant · cites it directly · 1 of its ownK131386 EZ-OX Plus Generation IIAir Liquide Healthcare America · 2014
- Descendant · 2 generations on · 0 of its ownK161179 Intelli-OxAir Liquide Healthcare America Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK142149 Oxytote Infinity Series Vipr SystemsWestern/Scott Fetzer Co. · 2015 · Recalled
- Descendant · cites it directly · 0 of its ownK080243 Portable Oxygen Unit SCA900San Cheong Co., Ltd. · 2009
Most influential descendants
Showing 5 of 5 · See all- K143060Intelli-OxAir Liquide Healthcare · 2015 · cites it directly1descendant
- K131386EZ-OX Plus Generation IIAir Liquide Healthcare America · 2014 · cites it directly1descendant
- K161179Intelli-OxAir Liquide Healthcare America Corporation · 2017 · 2 generations on0descendants
- K142149Oxytote Infinity Series Vipr SystemsWestern/Scott Fetzer Co. · 2015 · 2 generations on0descendants
- K080243Portable Oxygen Unit SCA900San Cheong Co., Ltd. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033897 | Medicyl-E-Lite Portable Oxygen Delivery System | Aga-Linde Health Care | 2004 | — |
| 0 (this device) | K053117 | EZ-OX Plus | Air Liquide Healthcare America | 2006 | — |
| +1 | K143060 | Intelli-Ox | Air Liquide Healthcare | 2015 | — |
| +1 | K131386 | EZ-OX Plus Generation II | Air Liquide Healthcare America | 2014 | — |
| +2 | K161179 | Intelli-Ox | Air Liquide Healthcare America Corporation | 2017 | — |
| +2 | K142149 | Oxytote Infinity Series Vipr Systems | Western/Scott Fetzer Co. | 2015 | 5 |
| +1 | K080243 | Portable Oxygen Unit SCA900 | San Cheong Co., Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K033897 | Medicyl-E-Lite Portable Oxygen Delivery SystemSummary page 2…ylinder pressure regulators and gas pressure gauges are Class I devices and exempted from pre-market notification. 5. PREDICATE DEVICE(s) * 5 10(k) No: K033897: MEDICYL-E-Lite Portable Medical Oxygen System (Linde) 6. DEVICE DESCRIPTION The EZ-OX Portable Oxygen Syst… | 2004 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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.
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 is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults; a pressure regulator, flow meter and medical E-Oxygen cylinder with handle and shroud all integrated into a single, lightweight unit. Key specifications include hose barb connection, protective cap, carrying handle, easy to read content gauge, indexed flow meter, integrated regulator and usage chart label with safety instructions. Medical…
Read the full statement (139 words)
The EZ-OX Plus is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults; a pressure regulator, flow meter and medical E-Oxygen cylinder with handle and shroud all integrated into a single, lightweight unit. Key specifications include hose barb connection, protective cap, carrying handle, easy to read content gauge, indexed flow meter, integrated regulator and usage chart label with safety instructions. Medical personnel can concentrate on providing patient care and treatment sooner without delays caused by the need to mount a regulator. With no assembly needed and the easy-to-use design, it is easy to operate.
For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053117 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053117: EZ-OX Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053117
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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