510(k) Report

510(k) · Cleared

Cleared

Liv Linde Intergrated Valve-Portable Oxygen System, Model M706

K101792510(k) TraditionalCleared Mar 18, 2011263-day reviewClass I21 CFR 868.2700

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Linde Gas North America, LLC · ECX Cylinder, Compressed Gas, And Valve

Cleared on Mar 18, 2011 as substantially equivalent to K063354 (Linde Gas Therapeutics, 2007) and 1 other predicate after a 263-day review. Its family tree reaches back 2 generations to 2004. 3 later devices descend from it.

Decided
Mar 18, 2011
Review
263 days
Class
Class I
Product code
ECX
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K033897 (2004). 3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2016: 2 descendants cleared2014: 1 descendant clearedK033897 · Medicyl-E-Lite Portable Oxygen Delivery System · Aga-Linde Health Care · 2004K063354 · Linde Integrated Valve (Liv) · Linde Gas Therapeutics · 2007200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 1 descendant K063354 · Linde Integrated Valve (Liv) · Linde Gas Therapeutics · 2007K033897 · Medicyl-E-Lite Portable Oxygen Delivery System · Aga-Linde Health Care · 20040
  1. Root · 2 generations backK033897 Medicyl-E-Lite Portable Oxygen Delivery SystemAga-Linde Health Care · 2004
  2. 1 generation backK063354 Linde Integrated Valve (Liv)Linde Gas Therapeutics · 2007
  3. This deviceK101792 Liv Linde Intergrated Valve-Portable Oxygen System, Model M706Linde Gas North America, LLC · 2011
  4. Descendant · cites it directly · 1 of its ownK132778 Grab 'N GO Plus, Grab 'N GO DigitalPraxair Healthcare Services · 2014
  5. Descendant · cites it directly · 0 of its ownK161472 Walk-O2-BoutEssex Industries, Inc. · 2016
  6. Descendant · 2 generations on · 0 of its ownK153518 Medipure Oxygen-LC SystemPraxair Distribution, Incorporated. · 2016

Most influential descendants

Showing 3 of 3 · See all
  • K132778Grab 'N GO Plus, Grab 'N GO DigitalPraxair Healthcare Services · 2014 · cites it directly1descendant
  • K161472Walk-O2-BoutEssex Industries, Inc. · 2016 · cites it directly0descendants
  • K153518Medipure Oxygen-LC SystemPraxair Distribution, Incorporated. · 2016 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K033897Medicyl-E-Lite Portable Oxygen Delivery SystemAga-Linde Health Care2004—
−1K063354Linde Integrated Valve (Liv)Linde Gas Therapeutics2007—
0 (this device)K101792Liv Linde Intergrated Valve-Portable Oxygen System, Model M706Linde Gas North America, LLC2011—
+1K132778Grab 'N GO Plus, Grab 'N GO DigitalPraxair Healthcare Services2014—
+1K161472Walk-O2-BoutEssex Industries, Inc.2016—
+2K153518Medipure Oxygen-LC SystemPraxair Distribution, Incorporated.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201620
FIG. 1 — Lineage of K101792, 2004–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K063354Linde Integrated Valve (Liv)
Summary page 1
…ation Legally marketed devices to which equivalence isbeing c/aimed 570(k) #t LIV K063354 Medicyl-E-lite K033897…
Linde Gas Therapeutics2007—
*K033897Medicyl-E-Lite Portable Oxygen Delivery System
Summary page 1
…0(k) #t LIV K063354 Medicyl-E-lite K033897 Page 14 of 47 Traditional 51 0(k) Notification…
Aga-Linde Health Care2004—

Also cleared against K063354: 1 other device →

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K132778Grab 'N GO Plus, Grab 'N GO DigitalPraxair Healthcare Services20141
K161472Walk-O2-BoutEssex Industries, Inc.20160

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 7 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K132778 (Praxair Healthcare Services, 2014) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K063354.

How does its category compare?

All ECX devices

ECX Cylinder, Compressed Gas, And Valve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · ECX

1in 2017

2007: 12011: 12014: 22015: 22016: 22017: 1
2007high 2 (2014) · low 0 (2008)2026

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

2009: 92019: 52021: 12026 (partial year): 3
2007high 9 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ECX

1in 2025

2007: 42008: 62009: 32010: 72011: 72012: 22013: 22014: 62015: 62016: 12017: 42018: 12019: 12020: 12021: 42022: 12023: 32025: 1
2007high 7 (2010) · low 0 (2024)2025

MAUDE reports naming product code ECX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—04
20080—06
20090—93
20100—07
20111—07
20120—02
20130—02
20142—06
20152—06
20162—01
20171—04
20180—01
20190—51
20200—01
20210—14
20220—01
20230—03
20240—00
20250—01
20260—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. 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.

Cite this page

510(k) Report. “K101792: Liv Linde Intergrated Valve-Portable Oxygen System, Model M706.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101792

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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