510(k) · Cleared
ClearedMedipure Oxygen-LC System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Praxair Distribution, Incorporated. · ECX Cylinder, Compressed Gas, And Valve
Cleared on Jun 3, 2016 as substantially equivalent to K132778 (Praxair Healthcare Services, 2014) after a 178-day review. Its family tree reaches back 4 generations to 2004.
- Decided
- Jun 3, 2016
- Review
- 178 days
- Class
- Class I
- Product code
- ECX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K033897 (2004). No later device cites it as a predicate yet.
- Root · 4 generations backK033897 Medicyl-E-Lite Portable Oxygen Delivery SystemAga-Linde Health Care · 2004
- 3 generations backK063354 Linde Integrated Valve (Liv)Linde Gas Therapeutics · 2007
- 2 generations backK101792 Liv Linde Intergrated Valve-Portable Oxygen System, Model M706Linde Gas North America, LLC · 2011
- 1 generation backK132778 Grab 'N GO Plus, Grab 'N GO DigitalPraxair Healthcare Services · 2014
- This deviceK153518 Medipure Oxygen-LC SystemPraxair Distribution, Incorporated. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K033897 | Medicyl-E-Lite Portable Oxygen Delivery System | Aga-Linde Health Care | 2004 | — |
| −3 | K063354 | Linde Integrated Valve (Liv) | Linde Gas Therapeutics | 2007 | — |
| −2 | K101792 | Liv Linde Intergrated Valve-Portable Oxygen System, Model M706 | Linde Gas North America, LLC | 2011 | — |
| −1 | K132778 | Grab 'N GO Plus, Grab 'N GO Digital | Praxair Healthcare Services | 2014 | — |
| 0 (this device) | K153518 | Medipure Oxygen-LC System | Praxair Distribution, Incorporated. | 2016 | — |
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 |
|---|---|---|---|
| * | K132778 | Grab 'N GO Plus, Grab 'N GO DigitalSummary page 5…nt) Classification Panel: Anesthesiology Section 5 Page 1 of 4 5. Legally Marketed Predicate Device K132778, Grab ‘n Go Plus, Praxair Healthcare Services. 6. Device Description The Medipure Oxygen-LC System is an integrated medical… | 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)
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 12 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- None of the 4 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. 2016, 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 Medipure Oxygen-LC System is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to neonates, pediatrics, and adults. The device is intended for limited duration use, such as would be necessary during patient transport.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153518 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153518: Medipure Oxygen-LC System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153518
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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