510(k) · Cleared
ClearedMedicyl-E-Lite Portable Oxygen Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aga-Linde Health Care · ECX Cylinder, Compressed Gas, And Valve
Cleared on Jul 19, 2004 after a 216-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.
- Decided
- Jul 19, 2004
- Review
- 216 days
- Class
- Class I
- Product code
- ECX
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 3 citing it directly.
- This deviceK033897 Medicyl-E-Lite Portable Oxygen Delivery SystemAga-Linde Health Care · 2004
- Descendant · cites it directly · 5 of its ownK063354 Linde Integrated Valve (Liv)Linde Gas Therapeutics · 2007
- Descendant · cites it directly · 5 of its ownK053117 EZ-OX PlusAir Liquide Healthcare America · 2006
- Descendant · cites it directly · 3 of its ownK101792 Liv Linde Intergrated Valve-Portable Oxygen System, Model M706Linde Gas North America, LLC · 2011
- Descendant · 2 generations on · 1 of its ownK143060 Intelli-OxAir Liquide Healthcare · 2015
- Descendant · 2 generations on · 1 of its ownK132778 Grab 'N GO Plus, Grab 'N GO DigitalPraxair Healthcare Services · 2014
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K063354Linde Integrated Valve (Liv)Linde Gas Therapeutics · 2007 · cites it directly5descendants
- K053117EZ-OX PlusAir Liquide Healthcare America · 2006 · cites it directly5descendants
- K101792Liv Linde Intergrated Valve-Portable Oxygen System, Model M706Linde Gas North America, LLC · 2011 · cites it directly3descendants
- K143060Intelli-OxAir Liquide Healthcare · 2015 · 2 generations on1descendant
- K132778Grab 'N GO Plus, Grab 'N GO DigitalPraxair Healthcare Services · 2014 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033897 | Medicyl-E-Lite Portable Oxygen Delivery System | Aga-Linde Health Care | 2004 | — |
| +1 | K063354 | Linde Integrated Valve (Liv) | Linde Gas Therapeutics | 2007 | — |
| +1 | K053117 | EZ-OX Plus | Air Liquide Healthcare America | 2006 | — |
| +1 | K101792 | Liv Linde Intergrated Valve-Portable Oxygen System, Model M706 | Linde Gas North America, LLC | 2011 | — |
| +2 | K143060 | Intelli-Ox | Air Liquide Healthcare | 2015 | — |
| +2 | K132778 | Grab 'N GO Plus, Grab 'N GO Digital | Praxair Healthcare Services | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 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? (2)
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 |
|---|---|---|---|
| * | — | MEDICYL-E-Lite Portable Oxygen System Named without a submission number | |
| * | — | Praxair Grab n' Go Portable Medical Oxygen System Named without a submission number |
What descends from it? (11)
See all 113 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?
- Of its descendants, K063354 (Linde Gas Therapeutics, 2007) has gone furthest, with 5 descendants of its own.
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 MEDICYL-E-Lite is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR imaging for MRI systems up to 3.OT.
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/K033897 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033897: Medicyl-E-Lite Portable Oxygen Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033897
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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