510(k) · Cleared
ClearedWalk-O2-Bout
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Essex Industries, Inc. · ECX Cylinder, Compressed Gas, And Valve
Cleared on Nov 18, 2016 as substantially equivalent to K101792 (Linde Gas North America, LLC, 2011) after a 175-day review. Its family tree reaches back 3 generations to 2004.
- Decided
- Nov 18, 2016
- Review
- 175 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 backK063354 Linde Integrated Valve (Liv)Linde Gas Therapeutics · 2007
- 1 generation backK101792 Liv Linde Intergrated Valve-Portable Oxygen System, Model M706Linde Gas North America, LLC · 2011
- This deviceK161472 Walk-O2-BoutEssex Industries, Inc. · 2016
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 | 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 | — |
| 0 (this device) | K161472 | Walk-O2-Bout | Essex Industries, Inc. | 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 |
|---|---|---|---|
| * | K101792 | Liv Linde Intergrated Valve-Portable Oxygen System, Model M706Summary page 4…: ECX - Cylinder, Compressed Gas, and Valve 21 CFR 868.2700, Class I Predicate Device: K101792 – Linde – LIV Portable Oxygen System Device Description: The Walk-O2-Bout® regulator is designed to be installed on a medical gr… | 2011 |
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 4 companies; a new generation was cleared every 3.9 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K101792.
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 Walk-O2-Bout® is an integrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and adults in hospital, sub-acute care, and pre-hospital / ground transport settings. It is offered in models that are MR-conditional (per ASTM F2052-15), and intended for use during MR imaging for static magnetic fields of 3.0 T or less. 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/K161472 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161472: Walk-O2-Bout.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161472
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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