510(k) · Cleared
ClearedLinde Integrated Valve (Liv)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linde Gas Therapeutics · ECX Cylinder, Compressed Gas, And Valve
Cleared on Apr 17, 2007 as substantially equivalent to K033897 (Aga-Linde Health Care, 2004) after a 162-day review. Its family tree reaches back 1 generation to 2004. 5 later devices descend from it.
- Decided
- Apr 17, 2007
- Review
- 162 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, 2 citing it directly.
- Root · 1 generation backK033897 Medicyl-E-Lite Portable Oxygen Delivery SystemAga-Linde Health Care · 2004
- This deviceK063354 Linde Integrated Valve (Liv)Linde Gas Therapeutics · 2007
- 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 ownK132778 Grab 'N GO Plus, Grab 'N GO DigitalPraxair Healthcare Services · 2014
- Descendant · 2 generations on · 0 of its ownK161472 Walk-O2-BoutEssex Industries, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK153518 Medipure Oxygen-LC SystemPraxair Distribution, Incorporated. · 2016
- 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- K101792Liv Linde Intergrated Valve-Portable Oxygen System, Model M706Linde Gas North America, LLC · 2011 · cites it directly3descendants
- K132778Grab 'N GO Plus, Grab 'N GO DigitalPraxair Healthcare Services · 2014 · 2 generations on1descendant
- K161472Walk-O2-BoutEssex Industries, Inc. · 2016 · 2 generations on0descendants
- K153518Medipure Oxygen-LC SystemPraxair Distribution, Incorporated. · 2016 · 3 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) | K063354 | Linde Integrated Valve (Liv) | Linde Gas Therapeutics | 2007 | — |
| +1 | K101792 | Liv Linde Intergrated Valve-Portable Oxygen System, Model M706 | Linde Gas North America, LLC | 2011 | — |
| +2 | K132778 | Grab 'N GO Plus, Grab 'N GO Digital | Praxair Healthcare Services | 2014 | — |
| +2 | K161472 | Walk-O2-Bout | Essex Industries, Inc. | 2016 | — |
| +3 | K153518 | Medipure Oxygen-LC System | Praxair Distribution, Incorporated. | 2016 | — |
| +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 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 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…Gas cylinder pressure regulators and gas pressure gauges are Class I devices and exempted from pre-market notification. 6.0 PREDICATE DEVICE(S) K033897 MEDICYL-E-Lite Portable Oxygen System 7.0 DEVICE DESCRIPTION The Linde Integrated Valve TM ("LIV") isa portable ox… | 2004 |
What descends from it? (5)
2 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. 2007, 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 LIV is an integrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and adults. The device is MR-conditional (per ASTM standard 2503-05), and intended for use during MR imaging for MRI systems up to 3.0T. 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/K063354 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063354: Linde Integrated Valve (Liv).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063354
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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