510(k) · Cleared
ClearedIntelli-Ox
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Air Liquide Healthcare America Corporation · ECX Cylinder, Compressed Gas, And Valve
Cleared on Apr 13, 2017 as substantially equivalent to K143060 (Air Liquide Healthcare, 2015) after a 352-day review. Its family tree reaches back 3 generations to 2004.
- Decided
- Apr 13, 2017
- Review
- 352 days
- Class
- Class I
- Product code
- ECX
- Recalls
- None
- 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 backK143060 Intelli-OxAir Liquide Healthcare · 2015
- This deviceK161179 Intelli-OxAir Liquide Healthcare America Corporation · 2017
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 | K143060 | Intelli-Ox | Air Liquide Healthcare | 2015 | — |
| 0 (this device) | K161179 | Intelli-Ox | Air Liquide Healthcare America Corporation | 2017 | — |
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 |
|---|---|---|---|
| * | K143060 | Intelli-OxSummary page 5…Dental Devices. 5. PREDICATE DEVICE(S) The following device is the legally marketed device to which equivalence is being claimed: Intelli-Ox, K143060, Air Liquide Healthcare 6. DEVICE DESCRIPTION The Intelli-OX portable oxygen delivery system that supplies Oxygen USP us… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 4 companies; a new generation was cleared every 1.9 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. 2017, 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 Intelli-OX is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla. When administered by properly trained personnel for oxygen deficiency and resuscitation, the Intelli-Ox is for emergency use only. For all other medical applications, the device is Rx only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161179 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161179: Intelli-Ox.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161179
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